about our company

CARDIOFOCUS
PUTTING PVI CONTROL IN A WHOLE NEW LIGHT

At CardioFocus, we specialize in providing electrophysiologists with innovative and effective tools that bring new levels of precision and control to the treatment of atrial fibrillation.

Our focused dedication on advancing cardiac ablation treatments has resulted in the ground-breaking HeartLight® Endoscopic Ablation System, integrating important new features into a never-before-seen platform as advanced as it is intuitive. And our ongoing research is taking laser ablation therapies to exciting new places.


THE HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
MAKING PVI CONTROL MORE ACCESSIBLE THAN EVER

The HeartLight Endoscopic Ablation System provides physicians with a number of unique and valuable new capabilities. Now, they can directly visualize anatomies intra-procedure, precisely target the application of laser energy, and deliver durable pulmonary vein isolation.

News

Events

Japanese Heart Rhythm Society

July 1-4, 2021

VIRTUAL

Heart Rhythm Society

July 28 – 31, 2021

Boston, MA

LEADERSHIP

BURKE BARRETT

BURKE BARRETT

Chief Executive Officer & President

BURKE BARRETT

Chief Executive Officer & President
Mr. Barrett currently serves as Chief Executive Officer (CEO) & President, having held senior leadership roles at CardioFocus for over 15 years.  He brings to CardioFocus 35 years of medical device industry experience including over 20 years of executive experience.  Previously, Mr. Barrett was Vice President of Clinical Operations at Cyberkinetics Neurotechnology Systems, Inc., a public medical device company that achieved first-in-man success in novel, implantable brain-computer interfaces. He also served at Cyberonics as the Vice President, Business and Technology Development.  Prior to that, Mr. Barrett held positions in business development, clinical, regulatory and quality at Biofield Corporation, Dornier Medical Systems, and Bausch & Lomb.  From 2010-2013 he served as the industry representative on the FDA's Circulatory Systems Device Advisory Panel. He received bachelor’s degrees in chemical engineering and chemistry from Syracuse University and a Master of Business Administration from Kennesaw University in Atlanta.

STEVE OGILVIE

STEVE OGILVIE

Chief Financial Officer

STEVE OGILVIE

Chief Financial Officer
Mr. Ogilvie joined CardioFocus in 2021 and currently serves as Chief Financial Officer (CFO), leveraging decades of experience in the medical technology sector, including leadership roles in sales, marketing and corporate development, as well as investment banking and sell side equity research. Most recently, he served as Managing Director of Healthcare Investment Banking at B Riley Securities, leading the firm's investment banking advisory engagements with healthcare companies. Previously Mr. Ogilvie served as Vice President, Corporate Development at NuVasive, where he led a variety of key functions, including mergers and acquisitions and the expansion of the company's global sales infrastructure. He has also held medical technology sell-side equity research positions at ThinkEquity Partners and Lazard Capital Markets, and was a product manager at Medtronic. Mr. Ogilvie earned his B.A. from Brigham Young University and his M.B.A. from New York University's Stern School of Business.

REBECCA ANDERSON

REBECCA ANDERSON

VP, Program Management

REBECCA ANDERSON

VP, Program Management
Ms. Anderson joined CardioFocus in 2018 as Vice President, Program Management. She brings over 20 years of experience in the medical device industry in a variety of functional areas including product development, program management, and continuous improvement. She was previously Director of Program Management, Global Product Development at Haemonetics, where she led a team of project and program managers responsible for the successful management of a global portfolio of product development programs. Ms. Anderson also held positions at OmniGuide Surgical and Philips Medical. She received a BS in Mechanical Engineering from MIT and a Master of Engineering in Mechanical Engineering from Carnegie Mellon University.
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MARK CASEY

MARK CASEY

VP, Operations

MARK CASEY

VP, Operations
Mr. Casey has over 25 years of domestic and international leadership experience in the Medical device and Capital equipment industries. He has extensive experience with Supply Chain development, Contract Manufacturing, production transfer and new facility start up. Past roles have included V.P. of Manufacturing and Supply Chain for Ivenix, a start-up medical device company developing a large volume infusion pump, V.P. of Global Manufacturing for Optos and Executive Director of Operations for Olympus – GyrusACMI. He received a bachelor’s degree in Mechanical Engineering with a Minor in Industrial Engineering from the University of Dayton. Additionally, he has multiple certifications in Supply Chain Management including, CPIM Production and Inventory Management and CSCP, Certified Supply Chain Professional. He also has extensive Lean Manufacturing experience and has a Six Sigma Greenbelt.

IAN CHRISTIANSON

IAN CHRISTIANSON

VP, Regulatory Affairs & Quality Assurance

IAN CHRISTIANSON

VP, Regulatory Affairs & Quality Assurance
Mr. Christianson joined CardioFocus in October 2009, bringing over 10 years of experience in quality assurance and operations experience in medical devices and the defense industry. He was previously Director of Quality Assurance and Regulatory Affairs at Concordia Medical, a contract manufacturer of medical devices and tissue engineering scaffolds. Mr. Christianson has held positions at Boston Scientific, Genzyme Biosurgery, and Johnson & Johnson. He received a Bachelor’s degree in Industrial Engineering from the University of Arizona, a Master’s degree in Industrial Engineering from Texas A&M University, and an MBA from the University of Massachusetts-Dartmouth.

SCOTT FLETCHER

SCOTT FLETCHER

VP, Finance & Administration

SCOTT FLETCHER

VP, Finance & Administration
Scott Fletcher joined CardioFocus in February 2017 bringing over 15 years of experience in the medical device industry.  Prior to joining CardioFocus Mr. Fletcher served as Vice President Finance and Administration at Holmed (later a part of NN Inc.), a firm specializing in the design and manufacturer of spine and orthopedic surgical instrumentation. At Holmed Mr. Fletcher led the finance, accounting, human resources and IT departments.  Mr. Fletcher previously held positions as Director of Finance for Precision Engineered Products, an orthopedic medical device manufacturer and as Site Controller for SMTC, an electromechanical manufacturing company focused on the technology sector.  He received a BS in Business Administration from the University of Vermont in 1998.
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STUART JAMESON

STUART JAMESON

VP, International

STUART JAMESON

VP, International
Mr. Jameson joined CardioFocus in 2017 as Managing Director, International with over 25 years’ experience within the cardiology and cardiac electrophysiology medical device fields. Prior to CardioFocus, Mr. Jameson held several leadership roles within Europe as Marketing Director, EMEA for St Jude Medical and Abbott based in Brussels, Belgium and European Sales Director, Endosense SA located in Geneva, Switzerland where he led the first successful commercial introduction of the TactiCathTM contact force sensing technology for radiofrequency ablation that has since become a gold standard in clinical practice. For 10 years with Biosense Webster, a Johnson & Johnson company, Mr Jameson provided key leadership within Europe to the successful and rapid expansion of cardiac electrophysiology technologies including market game changers such as irrigated ablation and the Carto® electro-anatomical mapping system, together with novel concepts such as the application of Six Sigma process improvement to healthcare.Mr. Jameson began his career as a qualified Cardiac Physiologist, attaining head of department level before transitioning into the medical device industry and holds a Bachelor’s Degree in Pure & Applied Mathematics.

SCOT MACDONELL

SCOT MACDONELL

VP, US Commercial

SCOT MACDONELL

VP, US Commercial
Mr. MacDonell joined CardioFocus in August 2019 as Vice President of US Commercial. He brings 25 years of experience in the medical device industry, including electrophysiology, cardiac rhythm management, heart failure, and diagnostics. Mr. MacDonell spent the majority of his career with St. Jude Medical where he most recently held the positions of Vice President of Sales and Vice President of Strategy and Disease Management. In these roles, he led teams responsible for launching several innovative technologies in electrophysiology, particularly in arrhythmia identification and therapy. Mr. MacDonell has also served as Vice President of Sales for early to mid-stage start-ups in the cardiac diagnostic space, helping to build and execute successful commercialization in the US market. He holds a BS in Biomedical Engineering from Texas A&M University and an MBA from Arizona State University.

JERRY MELSKY

JERRY MELSKY

VP, Engineering

JERRY MELSKY

VP, Engineering
Mr. Melsky joined the CardioFocus team in 2002 as Vice President of Engineering, bringing with him over 30 years of leadership experience in medical device design and development. He was previously Director of Mechanical Engineering for Infusaid corporation, the first company to receive IDE approval for an implantable drug pump. Mr. Melsky was also a co-founder of Therex corporation, where he developed a next-generation implantable drug infusion pump now marketed by Johnson and Johnson. Prior to joining CardioFocus, Mr. Melsky was Director of Engineering for Act Medical, now part of Accellent, Inc., where he headed a team of forty engineers and technicians developing a range of devices for minimally-invasive catheter-based procedures. He holds numerous patents in medical device designs, and a Bachelor’s and Master’s degree in mechanical engineering from M.I.T.
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LISA HAUSMANN

LISA HAUSMANN

Senior Director, Clinical Affairs

LISA HAUSMANN

Senior Director, Clinical Affairs
Ms. Hausmann joined CardioFocus in 2012 with over 20 years of experience in Clinical Affairs within the medical device industry. Her areas of expertise include early strategic planning; operations; safety; and data analysis and management for feasibility, IDE, and post-market clinical trials. Prior to CardioFocus, she held management positions at Augmenix, Inc., Innovative Spinal Technologies, Inc., OmniSonics Medical Technologies, Inc., and NxStage Medical, Inc. She has worked on products in a variety of therapeutic areas including cardiovascular, peripheral vascular, neurovascular, spine, radiation oncology, urology, and ESRD. Early in her career, Ms. Hausmann held positions of increasing scope and responsibility over a period of 11 years at Boston Scientific Corporation. Ms. Hausmann received a Bachelor’s degree from the University of California at Davis and earned her Master’s in Public Health with a concentration in biostatistics and epidemiology at Boston University.
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BOARD OF DIRECTORS

  • Paul LaViolette

    Mr. LaViolette serves as Chairman of the Board of Directors at CardioFocus.

    He is the Managing Partner and Chief Operating Officer at SV Health Investors, bringing more than 35 years of global medical technology management experience. Previously, he served as the Chief Operating Officer of Boston Scientific Corporation (BSC), an $8 billion medical device leader. During his 15 years at BSC, he also held positions including: Group President Cardiovascular; President, Cardiology; Group President, Endosurgery; and President, International during a period in which revenues grew 20 times. Mr. LaViolette integrated two dozen acquisitions and led extensive product development, operations and worldwide commercial organizations. He previously held marketing and general management positions at CR Bard, and various marketing roles at Kendall (Covidien).

  • Omar Amirana, MD

    Dr. Amirana has a unique combination of operating and venture capital experience in both medtech and pharma/biotech and has cross fertilized various disciplines throughout his career. He has served as an operator, board member and investor since 2005 and prior to that was in operating roles. He currently serves as CEO of LuxMed Systems. He most recently managed the life sciences portfolio at Allied Minds, an investment / IP commercialization vehicle which is publicly listed on the London Stock Exchange. Prior to that he was a Partner at Oxford BioScience Partners where he sourced deals, led investments and served on numerous boards. His investing and operating experience covers medical devices, drug discovery and healthcare IT/data analytics. Omar has served on over 20 boards and has participated in over $1billion of capital raises and transactions. Prior to his ~14 years in venture capital, he served in Silicon Valley for 11 years where he co-founded or held varying operating roles in 4 life sciences startups (3 went public on NASDAQ). He participated in an IPO roadshow for an electrophysiology company he co-founded, Cardima, which was a spin-off of Target Therapeutics and was funded by Kleiner Perkins and NEA. After Silicon Valley, he served as VP of Business Development for the electrophysiology business unit at St Jude Medical (STJ; now Abbott) in Minneapolis, MN while managing an advanced development group of ~20 engineers. Omar has worked with numerous investors, Scientific Advisory Boards, inventors and investigators. He is an inventor on numerous issued patents and is passionate about the intersection of life sciences and technology. Omar loves the beach, basketball, golf, paddle ball, the outdoors, travel and spending precious time with his wife, daughters, family and dog.

  • Burke Barrett

    Mr. Barrett joined CardioFocus in 2002 and currently serves as Chief Executive Officer (CEO) & President, leveraging over 30 years of medical device industry experience into the role of CEO. During his more than 15 years with the company has held roles of increasing responsibility from Vice President through to CEO & President.  Previously, Mr. Barrett was Vice President of Clinical Operations at Cyberkinetics Neurotechnology Systems, Inc., a public medical device company that achieved first-in-man success in novel, implantable brain-computer interfaces. He also served at Cyberonics as the Vice President, Business and Technology Development. Previously, Mr. Barrett held positions in business development, clinical & regulatory affairs, and quality auditing at Biofield Corporation, Dornier Medical Systems, and Bausch & Lomb.  From 2010-2013 he served as the industry representative on the FDA’s Circulatory Systems Device Advisory Panel. He received bachelor’s degrees in chemical engineering and chemistry from Syracuse University and a Master of Business Administration from Kennesaw University in Atlanta.

  • Charles Larsen

    Mr. Larsen is a co-founder and Managing Director of Accuitive Medical Ventures. He brings over 45 years of operating experience, as well as expansive technical understanding and experience in the medical device industry. Mr. Larsen was a co-founder of Novoste Corporation, where his efforts as a director and executive were critical to its ultimate success. Mr. Larsen also co-founded The Innovation Factory, through his role at TIF, Mr. Larsen has co-founded numerous companies including: Acufocus, AqueSys, Halscion, LipoSonix, Neuronetics and Sebacia. He holds over 30 issued U.S. and international patents on medical devices.

  • Bruce Robertson, PhD

    As Managing Director of H.I.G. BioHealth Partners, Dr. Robertson focuses on investment opportunities in the life sciences sector, including biopharmaceuticals, medical devices, and diagnostics. Dr. Robertson has been active in the life sciences sector for more than 30 years. Dr. Robertson currently serves on the boards of Apollo Endosurgery, RxSight, CardioFocus, Clarus Therapeutics, Iconic Therapeutics, Exagen, Zerigo Health, and Augmedics. Prior to joining H.I.G., he served most recently as Managing Director at Toucan Capital, a venture capital fund focusing on life science investments. While at Toucan, Dr. Robertson invested in leading drug and device companies throughout the U.S. Prior to Toucan, he was a General Partner at GIV Venture Partners, a venture capital firm focused on early stage investments in the US, India, and China. Prior to his private equity career, Dr. Robertson was Director of Business Development at IGEN International, where he was responsible for formulating and implementing IGEN’s partnering and M&A strategies.

     

    Dr. Robertson holds a BSE in Chemical Engineering and BA in Mathematics from the University of Pennsylvania, a PhD in Chemical/Biomedical Engineering from the University of Delaware, and an MBA with High Distinction from Harvard Business School.

  • Patrick Wethington

    Mr. Wethington is a serial CEO and entrepreneur. He has been involved with a unique list of “market innovation firsts” to tackle some of the leading chronic diseases of our time. Mr. Wethington has had four consecutive M&A exits (Medtronic, St. Jude Medical, Gambro and CryoLife), two as a CEO and two as a global market/commercial lead, and has had a fundraise plus exit value generation track record now approaching over $1 billion (venture, IPO and strategic fundraise-exit). Rounding out this experience, Mr. Wethington has for profit (private and public co.) and not-for-profit independent board member, audit committee chair, oversight committee member, strategic advisor, mentor and leadership experience at medical device, digital healthcare, and academic based organizations. Five years before the Covid-19 pandemic, Mr. Wethington started, co-invented and led the world’s first percutaneous neuromodulation stimulation device company to help wean patients off ventilators ($11.5B total addressable market TAM). Along with other ventures, Mr. Wethington is currently developing and forming a cardiac diagnostic company. Mr. Wethington serves as an Oversight Committee Member on the Technology and Validation Program Committee at Case Western Reserve University, and a mentor for Pre- and Post-Doctoral Biomedical Research Students enrolled in an NIH-funded EB4 program hosted by Washington University. Mr. Wethington currently serves as a strategic advisor for a publicly traded respiratory company.

INVESTORS

  • Accuitive Medical Ventures

    Accuitive Medical Ventures is a venture capital firm with committed capital of $230 million. A market-driven firm looking for revolutionary medical device technology investment opportunities, Accuitive has offices in Atlanta, GA and Amelia Island, FL.

  • Aurora Funds

    Aurora Funds is a family of venture capital funds committed to providing resources to help early stage healthcare and information technology companies reach their full potential. Aurora’s investment team has the experience, strategic relationships and capital to help companies accelerate their growth and gain a strong competitive advantage in their market space. Since its founding in 1994, Aurora has invested in over 60 portfolio companies, resulting in five IPOs and eight M&A transactions.

  • BioMed Ventures

    BioMed Ventures is the strategic investment arm of BioMed Realty. Acquired by Blackstone in 2016, BioMed Realty is the leading provider of real estate solutions to the life science industry – providing leasing, development, construction, redevelopment, acquisition, financing and property management to clients in the United States and United Kingdom, with over 12 million square feet of rentable space worldwide.

  • Fletcher Spaght Ventures

    Fletcher Spaght Ventures, (FSV) is a balanced-stage venture capital firm investing in high growth opportunities in healthcare/life sciences and related information technology companies. FSV was established in 2001 by Fletcher Spaght, Inc. (FSI), a strategy consulting firm founded in 1983. The FSI:FSV collaboration provides key differentiation from other venture capital firms and allows for significant advantages in deal sourcing and investing.

  • HIG BioHealth Partners

    With $400 million in assets under management, H.I.G. BioHealth Partners invests in a broad range of healthcare companies across multiple sectors and stages of development. Its seasoned investment team has extensive and diverse experience in big pharma, small biotech, medical devices, diagnostics, basic science, clinical research, and technology transfer. It invests in companies developing novel products for significant unmet medical needs.

  • Kestrel Management

    Kestrel Management invests in early stage healthcare companies. Investments other than CardioFocus include Health Dialog (disease management), PHT Corp. (Clinical trial support), Iora Healthcare (patient centric primary care), and Constant Therapy (digital solutions to brain injury). Kestrel typically invests at the pre-revenue stage and partners with both angels and venture capital firms.

  • SV Health Investors

    SV Health Investors is a leading healthcare and life sciences venture capital and growth equity firm. Its goal is to transform healthcare – one investment at a time – by supporting the entrepreneurs who create and build breakthrough companies and treatments. With over $2 billion in capital under management in seven private healthcare funds, a 20-year track record in the US and Europe and offices in Boston, San Francisco and London, SV Health Investors drives game-changing innovation.

CAREERS

  • QUALITY ENGINEER I

    Job Title:                  Quality Engineer I                                

    Department:             Quality Assurance    

    Job Reports To:       Quality Manager / Director of QA

    FLSA:                         Exempt

     

    Position Overview:

    The Quality Engineer I shall be responsible for the following activities/job functions:

    • Support manufacturing activities to continually improve product quality. Develop and implement inspection procedures. Participate in the disposition of non-conforming material and the investigation into root causes and implementation of corrective and preventive actions.
    • Support incoming, in-process, and final inspections of components and finished goods. Maintains the procedures, policies and systems needed to meet the requirements of the Company’s Inspection System. Manages maintenance and archival storage of incoming records and documents.
    • Provides support to the Company’s Preventive Maintenance and Calibration Programs. Maintains the procedures, policies and systems needed to meet the requirements of the Company’s internal PM and Calibration system requirements. Ensures timely calibration of devices and maintenance of equipment. Ensures maintenance and archival storage of all records, files and documents related to the Company’s PM and Calibration systems.
    • Support complaint handling process with assistance in determination of root cause of confirmed complaints, and work with other functions at CardioFocus to determine and implement corrective actions. Draft and author complaint response communication to customers for completed complaint investigations.
    • Assist in implementing and maintaining the quality management system, including corrective and preventive actions, calibration, preventive maintenance, and internal and external quality audits.
    • Other activities as directed to support the Company’s quality goals and objectives.

     
    Minimum Qualifications:

    Undergraduate college degree (bachelor) in an engineering discipline and 0-3 years of work experience.

    • Must have strong interpersonal skills and the ability to interface well with all employees.
    • Must have excellent organizational skills.
    • Must be thorough and detail oriented.
    • Must have excellent reading, proofreading, editing and technical writing skills and verbal communication skills in the English language.
    • Must be proficient in the use of Microsoft Office.
    • Ability to work within strict deadlines. Requires individual that can accurately and efficiently work on multiple projects and/or activities.
    • Basic knowledge of statistics and statistical techniques.
    • Basic knowledge of quality planning, data collection, and charting.

     
    Skills and Abilities Required:

    • Ability to prioritize, plan and execute work activities efficiently to meet company, department, and project goal.
    • Demonstrated accuracy and thoroughness with strong level of attention to detail; ability to monitor own work to ensure quality.
    • Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • QUALITY SPECIALIST

    Job Title:                  Quality Specialist                                

    Department:             Quality Assurance    

    Job Reports To:       Director of Quality & Regulatory Compliance

    FLSA:                         Non-Exempt / Exempt

     

    Position Overview:

    The candidate will be responsible for critical administrative and project focused tasks supporting the Quality department team with day-to-day activities.

    • Assist with review and approval of DHR level documentation using high level of attention to detail.
    • Assist with CardioFocus Training program for the issuance, retrieval and scanning prior to filing of required reports and creation of new employees within database.
    • Assist as back-up for Document Control responsibilities as assigned.
    • Scanning and filing of critical QA, RA and CA department documentation as assigned.
    • Assist with compiling of Regulatory and Clinical Department submissions and reports.
    • Additional tasks and responsibilities as assigned.

     
    Minimum Qualifications:

    • Associates Degree preferred at minimum.
    • 1-3 years in a professional administrative or office environment.
    • Proficient in Microsoft Outlook, Word, Excel and PowerPoint.
    • Attention to Detail.
    • Positive Attitude and ability to work with all levels of company’s personnel and departments.

     
    Skills and Abilities Required:

    • Ability to prioritize, plan and execute work activities efficiently to meet company, department, and project goal.
    • Demonstrated accuracy and thoroughness with strong level of attention to detail; ability to monitor own work to ensure quality.
    • Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be on their feet and mobile for 8 hours minimum a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, work at a computer, and review documentation.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • HR AND ACCOUNTING SPECIALIST

    Job Title:                   HR and Account Specialist

    Department:             General and Administrative

    Job Reports To:       Controller

    FLSA:                         Exempt

     

    Position Overview:

    Responsible for administrative duties including payroll and human resources related functions.
     
    Responsibilities::

    • Process payroll for US and European operations.
    • Manage human resources function including benefit administration, renewals, and employee onboarding.
    • Oversee company expense reimbursement program.
    • Monitor and track company wide PTO usage.
    • Assist with implementation and oversight of Compliance Program.
    • Set up and manage multi state and country payroll jurisdictions.
    • Recruit candidates using contracted agencies and other professional forums.
    • Sort, organize and match invoices received to open purchase orders, packing lists, inspection reports (as necessary) and receiving forms.
    • Verify invoice accuracy for quantities received, goods purchased, and prices displayed on purchase orders, inspection and receiving forms. Resolve any discrepancies as needed.
    • Code invoices to the correct general ledger account and cost center.
    • Match open invoices to printed checks and file in an alphabetical physical Paid Checks file.

     
    Minimum Qualifications:

    • Must have knowledge of payroll systems (preferably ADP).
    • Must be able to manage an ERP system. Experience with Epicor helpful.
    • Must exhibit a high level of discretion and confidentiality in dealing with sensitive company information.
    • Must have good organizational skills.
    • Must be thorough and detail oriented.
    • Must have excellent reading, writing and communication skills in the English language.
    • Must be able to work independently with little supervision.
    • Must have excellent problem-solving skills.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • SALES AND CONTRACT ADMINISTRATOR

    Job Title:                   Sales and Contract Administrator

    Department:             US Sales

    Job Reports To:       Vice President, US Commercial

    FLSA:                         Exempt

     

    Position Overview:

    The Sales and Contract Administrator will work primarily with our Sales Team to create, execute, and maintain customer contracts and pricing records, and provide valuable analysis to support the sales effort.
     
    Responsibilities::

    • Generate, review, and manage contracts from initial request to execution .
    • Coordinate with sales team, management, and/or lawyers as needed.
    • Work collaboratively with Finance to obtain and report sales data.
    • Analyze, format, and distribute sales data as needed by sales leadership.
    • Autonomously translate data to information for rapid digestion by the sales team .
    • Ensure agreements are appropriately organized and filed within contact folders .
    • Discuss contract terms and conditions with managers and interested parties.
    • Analyze potential risks related to specific contract terms.
    • Remain current with legislative changes and Company compliance policy.
    • Maintain and distribute sales and contract status reports .
    • Draft and administer commission compensation letters .
    • Manage returns administration for sales team .
    • Support Customer Service as needed.

     
    Minimum Qualifications:

    • Experience with Healthcare contracting is required, especially at the hospital/group purchasing organization (GPO) level.
    • Experience with pricing is required; experience with comparable products (catheters and disposables) is preferred.
    • Understanding of contract legalese is required.
    • Excellent writing skills.
    • Strong excel skills to enable formatting, analysis, and interpretation of sales data.
    • Strong data base management abilities to store and organize sales information, account planning detail, and contracts.
    • Able to work productively independently and as part of a team.
    • Ability to work with varying seniority levels, including staff, managers and customers.
    • Strong communication skills are a must.
    • Excellent analytical and problem-solving skills.
    • Keen attention to detail.
    • Strong organizational and time management abilities.
    • B.S. Business Administration is preferred.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • MANUFACTURING/PROCESS ENGINEER

    Job Title:                  Manufacturing/Process Engineer                                

    Department:             Operations    

    Job Reports To:       Director of Manufacturing

    FLSA:                         Exempt

     

    Position Overview:

    Job Purpose: The candidate will be responsible for manufacturing and sustaining engineering for a complex optical catheter medical device that is manufactured in a controlled environment. Efforts will focus on improving and/or developing processes, tooling and fixtures for existing products or new products. Candidate will provide leadership, interface, and support for peers in other departments including Quality, Supply Chain, R&D, and Finance.

     

    Minimum Qualifications:

    Bachelor’s Degree in Electrical, Mechanical or Biomedical Engineering. Five years engineering experience in a medical device manufacturing environment. Catheter experience preferred. Solid knowledge of QSR, ISO 13485, and the MDD is highly desired. Familiarity with LEAN principles preferred. Must have ability to read, understand, and develop SOP’s, engineering drawings, and manufacturing procedures. Candidate must speak and understand English effectively. Excellent communication skills (verbal and written) required. Ability to collect, collate, and present data effectively. Grasp of statistical techniques a plus.

     

    Skills and Abilities Required:

    • Strong knowledge associated with catheter and optical systems.
    • Strong knowledge of Adhesive and Solvent bonding assembly of polycarbonates.
    • Ability to convert manual assembly processes to semi-automated processes.
    • Strong knowledge of manufacturing processes associated with single use medical devices.
    • Ability to prioritize, plan, and execute work activities efficiently and effectively to meet company, department, and project goals.
    • Demonstrated accuracy and thoroughness; ability to monitor own work to ensure quality.
    • Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be on their feet and mobile for 8 to 10 hours a day, move throughout the facility to accomplish required tasks, visually prepare and analyze data, work at a computer, and review assemblers’ work using a microscope and/or small tools and fixtures. Ability to lift/move/carry for short distances equipment weighing up to 25 lbs. Specific vision requirements of this job include close vision and ability to adjust focus.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • SENIOR QUALITY INSPECTOR

    Job Title:                   Senior Quality Inspector

    Department:             Quality

    Job Reports To:       Product Quality Manager or Quality Manager or Director, QA and Regulatory Compliance

    FLSA:                         Non-Exempt

     

    Position Overview:

    Quality Inspector will work in a controlled environment and will inspect medical devices.

    • Follows production drawings and procedures, or receives verbal instructions regarding duties to be performed.
    • Be able to follow and revise Quality and Manufacturing procedures for inspection purposes.
    • Documents and informs other of any material issues for prompt corrective action.
    • Positions and aligns parts in specified relationship to each other in a jig, fixture, or other holding device.
    • Inspect incoming materials, components, sub-assemblies and final products.
    • Performs other QA related functions collaboratively with Manufacturing such as assisting with DHR review, equipment calibration and PMs.
    • Performs go/not-go testing and inspection to ensure parts and assemblies meet production specifications and standards.
    • Interact with other Quality Associates and other department members.
    • Communicate and mentor junior QA and QI members in cleanroom.
    • Assists QA with Document Control and training records as needed or directed.

     
    Minimum Qualifications::

    • Education and/or Experience – Two to four years related experience and/or training; or equivalent combination of education and experience.
    • Two years’ experience working in Quality Assurance/ Quality Control preferred.
    • Minimum of 2-4 year experience working under s controlled environment performing Quality Control or Quality Assurance Duties.
    • Language Skills – Ability to read and understand SOP’s and manufacturing procedures. Ability to print and speak simple English sentences.
    • Mathematical Skills – Basic.
    • Reasoning Ability – Ability to apply good common sense to carry out multi-step written or verbal instructions.
    • Computer Skills – Basic.

     
    Skills and Abilities Required:

    • Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
    • Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Develops realistic action plans.
    • Professionalism – Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
    • Work Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
    • Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.
    • Attendance/Punctuality – Is consistently at work and on time.
    • Dependability – Follows instructions, responds to management direction; takes responsibility for own actions. Completes tasks in the agreed upon time.
    • Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities. Looks for and takes advantage of opportunities; Asks for and offers help when needed.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • QUALITY INSPECTOR

    Job Title:                   Quality Inspector

    Department:             Quality

    Job Reports To:       Quality Manager/Director of Quality

    FLSA:                         Non-Exempt

     

    Position Overview:

    • Follows production drawings and procedures, or receives verbal instructions regarding duties to be performed.
    • Be able to follow and revise Quality and Manufacturing procedures for inspection purposes.
    • Documents and informs other of any material issues for prompt corrective action.
    • Positions and aligns parts in specified relationship to each other in a jig, fixture, or other holding device.
    • Inspect incoming materials, components, sub-assemblies and final products.
    • Performs other QA related functions collaboratively with Manufacturing such as assisting with DHR review, equipment calibration and PMs.
    • Performs go/not-go testing and inspection to ensure parts and assemblies meet production specifications and standards.
    • Interact with other Quality Associates and other department members.
    • Communicate and distribute work to other Quality members in cleanroom.
    • Train other junior Quality Associates as needed.
    • Assists QA with Document Control and training records as needed.

     
    Minimum Qualifications::

    Requires at a minimum a BS in a science or engineering discipline with 2 or more years of medical device regulatory affairs; or an equivalent combination of education and experience.

    • Education and/or Experience – Zero to one year related experience and/or training; or equivalent combination of education and experience.
    • Two years’ experience working in Quality Assurance/ Quality Control preferred.
    • Minimum of 0-1 year experience working under s controlled environment performing Quality Control or Quality Assurance Duties.
    • Language Skills – Ability to read and understand SOP’s and manufacturing procedures. Ability to print and speak simple English sentences.
    • Mathematical Skills – Basic.
    • Reasoning Ability – Ability to apply good common sense to carry out multi-step written or verbal instructions.
    • Computer Skills – Basic.

     
    Skills and Abilities Required:

    • Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
    • Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Develops realistic action plans.
    • Professionalism – Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
    • Work Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
    • Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.
    • Attendance/Punctuality – Is consistently at work and on time.
    • Dependability – Follows instructions, responds to management direction; takes responsibility for own actions. Completes tasks in the agreed upon time.
    • Initiative – Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities. Looks for and takes advantage of opportunities; Asks for and offers help when needed.
    • Innovation – Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Presents ideas and information in an effective manner.

     
    The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

    Please submit your resume and cover letter to: careers@cardiofocus.com

  • DOCUMENT CONTROL ASSOCIATE/SPECIALIST

    Job Title:                   Document Control Associate/Specialist

    Department:             Quality Assurance

    Job Reports To:       Document Control Supervisor

    FLSA:                         Exempt

     

    Position Overview:

    Coordinating with Senior Document Control personnel, maintaining the CardioFocus document control system:

    • Establish and maintain procedures, policies and systems needed to meet the requirements of document control in a medical device company.
    • Receive, review and process document change requests.
    • Review change requests for accuracy, completeness and conformance to standard operating procedures.
    • Support accurate compilation of Design History Files, Device Master Records and Regulatory Technical Documentation associated with Doc Control Records.
    • Manage storage and archiving of quality system documents.

     
    Minimum Qualifications::

    Associates degree and 1+ years of document control experience in a related health-care field such as in a medical device or pharmaceutical company.

      Skills and Abilities Required:

      • Must have excellent people skills and be able to interface well with all employees.
      • Must have excellent organizational skills.
      • Must be thorough and detail oriented.
      • Must be proficient in the use of Microsoft Office applications, including at least one database program such as Access and editing applications such as Adobe Acrobat, etc.
      • Ability to work independently and resolve issues without detailed direction.
      • Ability to work within strict deadlines to meet multiple company project goals.
      • Working knowledge of current FDA QSR and ISO 13485 documentation requirements.
      • Must be able to maintain confidentiality and interact with all levels of an organization and sensitive information.

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com

    • REGULATORY AFFAIRS SPECIALIST II

      Job Title:                   Regulatory Affairs Specialist II

      Department:             Regulatory Affairs

      Job Reports To:       Manager, Regulatory Affairs

      FLSA:                         Exempt

       

      Position Overview:

      The Regulatory Affairs Specialist develops content and format for global regulatory submissions with a focus on PMAs, IDEs, and related supplements and amendments. Executes regulatory strategy for new and currently marketed product approval and supports negotiations with regulatory authorities regarding company filings involving appropriate methods including the QSub process. Serves as regulatory affairs representative on assigned teams to provide guidance on regulatory requirements and submissions resulting in product approvals. Review changes to products, processes, and promotional materials to determine regulatory requirements and manages ongoing reports and registrations.

      Minimum Qualifications::

      Requires at a minimum a BS in a science or engineering discipline with 2 or more years of medical device regulatory affairs; or an equivalent combination of education and experience.

      • US Class III medical devices with cardiac electrophysiology devices a plus.
      • US Class II 510(K) experience.
      • Involvement in international registrations a plus.

       
      Skills and Abilities Required:

      • Demonstrated leadership and career abilities and the ability to translate regulatory requirements into clear direction for the company.
      • Must collect and organize diverse information to develop regulatory strategies, guide the organization, and anticipate regulatory needs and fulfill them proactively.
      • Must support regulatory submission activities for company partners worldwide.
      • Must prioritize and plan work activities, use time efficiently, plan for additional resources, set goals and objectives, organize or schedule other people and their tasks, and develop realistic action plans.
      • Must write clearly and informatively; edit work for spelling and grammar; vary writing style to meet needs; present numerical data effectively; be able to read and interpret written information.
      • Must have a basic technical aptitude to assist in processing complex technical information and clinical test data and translate complex information into clear, concise regulatory submissions.

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com

    • REGULATORY AFFAIRS SPECIALIST I

      Job Title:                   Regulatory Affairs Specialist I

      Department:             Regulatory Affairs

      Job Reports To:       Manager, Regulatory Affairs

      FLSA:                         Exempt

       

      Position Overview:

      The Regulatory Affairs Specialist develops content and format for global regulatory submissions with a focus on PMAs, IDEs, and related supplements and amendments. Executes regulatory strategy for new and currently marketed product approval and supports negotiations with regulatory authorities regarding company filings involving appropriate methods including the QSub process. Serves as regulatory affairs representative on assigned teams to provide guidance on regulatory requirements and submissions resulting in product approvals. Review changes to products, processes, and promotional materials to determine regulatory requirements and manages ongoing reports and registrations.

      Minimum Qualifications::

      Requires at a minimum a BS in a science or engineering discipline with 2 or more years of medical device regulatory affairs; or an equivalent combination of education and experience.

      • US Class III medical devices with cardiac electrophysiology devices a plus.
      • US Class II 510(K) experience.
      • Involvement in international registrations a plus.

       
      Skills and Abilities Required:

      • Demonstrated leadership and career abilities and the ability to translate regulatory requirements into clear direction for the company.
      • Must collect and organize diverse information to develop regulatory strategies, guide the organization, and anticipate regulatory needs and fulfill them proactively.
      • Must support regulatory submission activities for company partners worldwide.
      • Must prioritize and plan work activities, use time efficiently, plan for additional resources, set goals and objectives, organize or schedule other people and their tasks, and develop realistic action plans.
      • Must write clearly and informatively; edit work for spelling and grammar; vary writing style to meet needs; present numerical data effectively; be able to read and interpret written information.
      • Must have a basic technical aptitude to assist in processing complex technical information and clinical test data and translate complex information into clear, concise regulatory submissions.

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com

    • PROJECT MANAGER

      Job Title:                    Project Manager

      Department:              Product Development

       

      Responsibilities:

      The Project Engineer position will be responsible for leading the design, development of new products, product improvements and new and improved production methods. The objective of this role is to lead focused project teams through the development process from concept to commercial launch. The right individual will have very strong problem solving abilities along with analytical skills and the ability to conceive creative solutions to both product design and manufacturing processes. As a project leader the Project Engineer will follow the CardioFocus Design Control system to develop project plans and execute on them maintaining accurate and complete records, interact with the cross-functional team, outside vendors and service suppliers. The position will also entail managing the Design History File, preparing supporting documentation for regulatory submissions and contributing inventions, new designs or techniques and solving unique technical problems.

      Requirements:

      • Minimum qualifications are a BS in an Engineering discipline and 6 years of experience in the medical device industry
      • Proven ability to lead medical device projects from concept through commercialization is a must
      • Specific experience developing catheters for cardiology, neurology, electrophysiology or structural heart applications is strongly desired
      • Must have knowledge of medical device regulations and experience in maintaining Design History Files and document change control
      • Strong communication, organization and planning skills are needed along with the ability to work in a small company start-up environment

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com

    • SENIOR CLINICAL RESEARCH ASSOCIATE

      Job Title:                  Senior Clinical Research Associate

      Department:             Clinical Affairs

      Job Reports To:       Senior Director of Clinical Affairs

      FLSA:                         Exempt

      Scope:

      Working with the Clinical Affairs team in a collaborative and cross functional setting, the Senior Clinical Research Associate will participate as a clinical team member in the management and execution of a Phase IV cardiovascular medical device trial.

      Responsibilities:

      • Provide overall clinical site management from start-up to close-out
      • Serve as liaison between sponsor and site Investigators and Study Coordinators regarding protocol questions, queries, and enrollment
      • Responsible for site communication and instruction on clinical processes
      • Maintain audit-ready Trial Master File via regulatory document collection, review, and tracking
      • Conduct remote (on sites as needed) Site Initiation Visits, Interim Monitoring Visits and Close-out Visits according to Monitoring Plan and Data Management Plan; activities to include source document verification, electronic CRF review, regulatory document review, and assessment of protocol and regulatory compliance
      • Complete clinical site status reports and monitoring reports; provide ongoing status updates to management
      • Facilitate clinical site contract and budget process
      • Develop clinical trial documents and materials
      • Interface with project team, data management CRO
      • Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, and GCP Guidelines

       
      Requirements:

      • BS or higher in biology, health, medical or clinical sciences (e.g., Physiology or Nursing)
      • 5+ years clinical research experience in a medical device (preferred) or CRO setting. Monitoring experience required, including two or more years of independent monitoring
      • Previous experience in a cardiovascular clinical trial preferred
      • Thorough understanding of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials
      • Experience with Electronic Data Capture (EDC) systems
      • Solid computer skills (Microsoft Word, Outlook, Excel, and PowerPoint)
      • Ability to work in fast paced, dynamic setting
      • Excellent interpersonal, organizational, and critical thinking skills
      • Strong written, verbal, and presentation skills
      • Positive, self-motivated, creative, detail- and solutions-oriented with the ability to work independently as well as collaboratively in a team environment
      • Travel: currently 0%

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com

    • CLINICAL RESEARCH ASSOCIATE

      Job Title:                  Clinical Research Associate

      Department:             Clinical Affairs

      Job Reports To:       Senior Director of Clinical Affairs

      FLSA:                         Exempt                

      Scope:

      Working with the Clinical Affairs team in a collaborative and cross functional setting, the Clinical Research Associate will participate as a clinical team member in the management and execution of a Phase IV cardiovascular medical device trial.

      Responsibilities:

      • Provide overall clinical site management from start-up to close-out
      • Serve as liaison between sponsor and site Investigators and Study Coordinators regarding protocol questions, queries, and enrollment
      • Responsible for site communication and instruction on clinical processes
      • Maintain audit-ready Trial Master File via regulatory document collection, review, and tracking
      • Conduct remote (on-site as needed) Site Initiation Visits, Interim Monitoring Visits and Close-out Visits according to Monitoring Plan and Data Management Plan; activities to include source document verification, electronic CRF review, regulatory document review, and assessment of protocol and regulatory compliance
      • Complete clinical site status reports and monitoring reports; provide ongoing status updates to management
      • Develop clinical trial documents and materials
      • Interface with project team, data management CRO
      • Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, and GCP Guidelines

       
      Requirements:

      • BS in biology, health, medical or clinical sciences (e.g., Physiology or Nursing)
      • 3+ years clinical research experience in a medical device (preferred) or CRO setting. Monitoring experience required, including one or more years of independent monitoring
      • Previous experience in a cardiovascular clinical trial preferred
      • Working knowledge of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials
      • Experience with Electronic Data Capture (EDC) systems
      • Solid computer skills (Microsoft Word, Outlook, Excel, and PowerPoint)
      • Ability to prioritize tasks in fast paced, dynamic setting
      • Excellent interpersonal, organizational, and critical thinking skills
      • Strong written, verbal, and presentation skills
      • Positive, self-motivated, creative, detail-oriented team player
      • Travel: currently 0%

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com

    • FIELD CLINICAL SPECIALIST

      Job Title:                   Field Clinical Specialist

      Department:             Sales / Field Support

      Job Reports To:       Managing Director

      FLSA:                         Exempt

       

      Scope:

      Working with the US Sales & Marketing team in a collaborative and cross-functional setting, the Field Clinical Specialist will participate with the US Sales & Marketing team in the field support and education using the Company’s unique Endoscopic Ablation System in the treatment of patients with atrial fibrillation (AF).

      Responsibilities:

      • Support US physicians and hospital staff when using the HeartLight Ablation system to treat AF according to industry standards and the product IFU
      • Support new site launches of the HeartLight catheter and console for ablation of atrial fibrillation in the US
      • Support communication with US Territory Managers and the Marketing team
      • Support selection of new centers
      • Support site personnel training on the use of the Company’s products according to the industry standards and the product IFU
      • Support site communication for device shipments and cases
      • Verify proper device shipment, accountability and disposition
      • Provide product feedback when necessary, including implant case report forms (CRFs) and complaint handling

       
      Requirements:

      • Four year engineering degree preferred
      • At least 1-2 years of hospital experience, ideally in the EP lab conducting ablations
      • At least 1 years working for a medical device EP company supporting clinical cases of AF pulmonary vein isolation (PVI) ablation or similar experience
      • Prior positive relationships with AF ablation centers in the US preferred
      • Ability to work in fast paced dynamic setting
      • Excellent interpersonal, organizational, and critical thinking skills; able to interface with leading thought leaders in the field of AF ablation
      • Positive, self-motivated, creative, detail oriented team player
      • Travel: Up to 70%
      • Able to withstand physical requirements of supporting AF cases while wearing lead
      • Able to withstand physical requirements of travel

       
      The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job’s end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

      Please submit your resume and cover letter to: careers@cardiofocus.com