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

NOVEMBER 1-2, 2018
ARNHEM, NETHERLANDS

NVVC


NOVEMBER 10-12, 2018
CHICAGO, IL

AHA


DECEMBER 4-6, 2018
ROME, ITALY

PCP


JANUARY 24-26, 2019
BOSTON, MA

AF SYMPOSIUM

LEADERSHIP

  • PAUL LAVIOLETTE
    Executive Chairman

    PAUL LAVIOLETTE

    Mr. LaViolette has served as the Executive Chairman of CardioFocus since 2013, 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).

    In addition to the Executive Chairman role at CardioFocus, Mr. LaViolette is the Managing Partner and Chief Operating Officer at SV Life Sciences, serves as the Vice Chairman of the Innovation Advisory Board for the Partners Health System, and is the Chairman for the Medical Device Manufacturers Association.

  • BURKE BARRETT
    President & Chief Operating Officer

    BURKE BARRETT

    Mr. Barrett joined CardioFocus in 2005 and currently serves as the President & Chief Operating Officer (COO), leveraging over 30 years of medical device industry experience and over 15 years of executive experience into the role of COO. From 2010-2013 he served as the industry representative on the FDA’s Circulatory Systems Device Advisory Panel.

    Prior to joining CardioFocus, 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. Mr. Barrett also served at Cyberonics as the Vice President, Business and Technology Development. In this role, he was responsible for finding new applications for Cyberonics’ novel, implantable nerve stimulation technology that included management of multiple first-in-man IDE trials.

    Previously, Mr. Barrett held positions in business development, clinical & regulatory affairs, and quality auditing at Biofield Corporation, Dornier Medical Systems, and Bausch & Lomb. Mr. Barrett is a co-inventor on numerous issued and pending patent applications. He received Bachelor’s Degrees in Chemical Engineering and Chemistry from Syracuse University and an MBA from Kennesaw University in Atlanta, GA.

  • OMARI BOUKNIGHT
    President & Chief Commercial Officer

    OMARI BOUKNIGHT

    Mr. Bouknight joined CardioFocus in 2016 and serves as its President & Chief Commercial Officer (CCO). He has substantial experience launching novel cardiac medical technologies on a global basis. Prior to joining CardioFocus, Mr. Bouknight held the role of Vice President of Sales and Marketing for Cardiac Dimensions, an early-stage cardiovascular company with an innovative mitral valve repair system. Prior to Cardiac Dimensions, he led the highly successful launch of the HeartMate II® Left Ventricular Assist System® at Thoratec Corporation, where he served in the role of Business Unit Director.

    Mr. Bouknight began his cardiovascular medical technology career at Guidant Corporation, working directly with electrophysiologists as a Certified Cardiac Device Specialist (CCDS). He holds an MBA from Harvard Business School and Bachelor’s degrees in Supply Chain Management, International Relations, and German from Michigan State University.

  • REBECCA ANDERSON
    Vice President, 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.

  • IAN CHRISTIANSON
    Vice President, Regulatory Affairs & Quality Assurance

    IAN CHRISTIANSON

    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.

  • DAVID KRESSLER
    Vice President, Operations

    DAVID KRESSLER

    Mr. Kressler joined CardioFocus in 2013, bringing over 25 years of operations experience in the medical device arena. He was previously VP of Operations at Kalypto Medical, manufacturer of a unique Negative Wound Therapy system. Mr. Kressler previously served as VP of Operations at Velocimed, a startup with three innovative cardiology products, transitioning to the same role at St. Jude Medical after a successful acquisition. Earlier in his career, he spent 14 years increasing scope and responsibility at Boston Scientific. Mr. Kressler received a Bachelor’s degree in Industrial Engineering from Northeastern University and a Master’s in Management from Lesley University.

  • JERRY MELSKY
    Vice President, Engineering

    JERRY MELSKY

    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.

  • JEFF RYNBRANDT
    Vice President, US Sales

    JEFF RYNBRANDT

    Mr. Rynbrandt joined CardioFocus in 2016 as Vice President of US Sales with a track record of building and leading cohesive sales teams within a variety of electrophysiology markets. He held various leadership roles in sales and marketing at Boston Scientific, and has extensive experience in new product launches. Prior to his 14-year sales career with Boston Scientific, Mr. Rynbrandt served more than six years as an Officer in the United States Army in multiple command and leadership positions. He earned an MBA from Michigan State University and a Bachelor’s degree from the United States Military Academy at West Point.

  • LEIGH WHITTAKER
    Vice President, Global Marketing & Education

    LEIGH WHITTAKER

    Ms. Whittaker joined CardioFocus in 2011, bringing over 20 years of professional experience in the healthcare and medical device industries. She was previously Business Development Manager at Bard Electrophysiology, as well as a Clinical Specialist for Medtronic Cardiac Rhythm Management.  Ms. Whittaker is a registered nurse (RN) certified by the International Board of Heart Rhythm Examiners as a Cardiac Device Specialist (CCDS) and as an EP Specialist (CEPS). Early in her career, Ms. Whittaker spent over 10 years as a critical care nurse in the Cardiac Surgical Intensive Care Unit at Massachusetts General Hospital and Electrophysiology Lab at Brigham and Women’s Hospital. Ms. Whittaker has a Bachelor’s degree in Economics and Finance from the University of Connecticut, and an MBA with a concentration in Finance from Suffolk University.

  • LISA HAUSMANN
    Senior Director, Clinical Affairs

    LISA HAUSMANN

    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.

BOARD OF DIRECTORS

  • Omar Amirana, MD

    Dr. Amirana leads the strategic direction and development of the Life Sciences portfolio for Allied Minds (LSE: ALM.L), a publicly traded company focused on venture creation and commercialization. In addition to serving as CEO of two Allied Minds portfolio companies, he also contributes to the Allied Minds joint ventures with Bristol-Myers Squibb and General Electric. Dr. Amirana previously served as Partner at Oxford Bioscience Partners, a Boston-based venture capital firm with ~$1B under management. There he led the Series A investment in nFocus Neuromedical (brain aneurysm therapy; acquired by Covidien), served on numerous boards and participated in numerous financings. He has also served on the board of the Ignition Awards Committee at BU and the Coulter Committee at Columbia University. He has co-founded or held varying senior executive roles in four startups and served as VP of Business Development at St Jude Medical (now Abbott; NYSE:ABT).

  • Chris Kroeger, MD

    Dr. Kroeger served as the President and Chief Executive Officer of Cardioxyl Pharmaceuticals from 2008 until its acquistion by Bristol Myers Squibb (BMY) in December of 2015, and served on the Company’s Board of Directors since 2006. Dr. Kroeger advised Cardioxyl through the initial stages of company formation, and then led the company through all phases of development from discovery through to late stage clinical studies of both CXL-1020 and CXL-1427, Cardioxyl’s lead assets in acute decompensated heart failure. He built and led a highly effective and efficient scientific, clinical and operations team that produced three IND candidates and successfully executed six Phase 1 and Phase 2 clinical studies. Dr. Kroeger also effectively financed the company’s activities, attracting over $80MM of private investment from multiple top tier venture capital firms. During his tenure, he negotiated numerous licenses and partnerships and engineered the ultimate sale of Cardioxyl to BMS for $2.1 billion in total consideration.

    Prior to joining Cardioxyl, Dr. Kroeger led the biopharmaceutical and medical device investing efforts for the Aurora Funds, a venture capital firm that he joined in 2003 and where he remains a Partner. He has been involved in the board governance and/or strategic oversight of fifteen venture backed drug and medical device companies and currently sits on the boards of CardioFocus and Cantex Pharmaceuticals. Of the five early stage companies in which Dr. Kroeger led direct investments for Aurora, two have FDA approved PMA medical devices, and two have completed successful Phase 2 clinical development of pharmaceuticals in areas of significant unmet medical need. Dr. Kroeger previously trained in General Surgery at Brigham and Women’s Hospital in Boston, part of the Harvard Medical System. He earned his MBA from Harvard Business School, his M.D. from Stanford University School of Medicine, and his BS from Harvard University.

  • Charles Larsen

    Mr. Larsen is a co-founder and Managing Director of Accuitive Medical Ventures. He brings over 35 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 with Tom Weldon where his efforts as a director and executive were critical to its ultimate success. Mr. Larsen also co-founded The Innovation Factory and serves as its Vice Chairman. Through his role at The Innovation Factory, 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.

  • Paul LaViolette

    Mr. LaViolette 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).

  • Greg Madden

    Mr. Madden is a Principal for SV Health Investors, a leading healthcare and life sciences venture capital and growth equity firm.  He joined the firm in 2002 and focuses on medical device and healthcare services investments.  He is actively engaged in the financing, strategy, operations, and acquisitions of portfolio companies.

    Prior to joining SV, Mr. Madden worked at Testa, Hurwitz & Thibeault, in the Business Practice, Emerging Technology, and Private Equity groups, supporting both venture capital funds and venture backed companies in business formations and financings, mergers and acquisitions, and venture capital fundraising.

  • 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 20 years. 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.

  • Patrick Wethington

    Mr. Wethington serves as the President and Chief Executive Officer of Stimdia Medical, Inc, a privately-held company which is developing products to treat patients with ventilator induced diaphragmatic dysfunction (“VIDD”).  He was previously the Chief Executive Officer and President of CardioInsight Technologies Inc. (acquired by Medtronic) as well as the Chief Executive Officer and President of Hemosphere, Inc. (acquired by CryoLife).  Mr. Wethington has more than 25 years of cross functional medical device experience in the cardiovascular industry, including leadership roles at Guidant, Endocardial Solutions (acquired by St. Jude Medical), St. Jude Medical Inc. and CHF Solutions, Inc. (acquired by Gambro).

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.

  • Industry Ventures

    Industry Ventures is a leading investment firm that focuses on venture capital. The firm has three investment strategies: secondary investments, primary fund of funds investments and direct co-investments. Founded in 2000, the firm manages over $3 billion of institutional capital and is headquartered in San Francisco with an office in Washington, D.C.

  • KBL Healthcare Ventures

    KBL brings a team of investment professionals with prior experiences as senior executives, clinical practitioners and venture capitalists. While it is capable of bringing managerial and technical expertise to an emerging company, it is also able to draw upon a rich network of contacts across multiple disciplines to foster the growth and development of its portfolio companies. KBL prides itself on developing lasting relationships with its entrepreneurs and looks to cultivate a professionally and personally rewarding experience for all involved.

  • 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.

  • SightLine Partners

    Sightline Partners is an alternative investment manager providing custom equity financing for differentiated, growth-stage healthcare companies. It invests in select, high-potential healthcare companies to unlock value others can’t. Through custom financing solutions and active management, Sightline Partners helps propel these companies to the exit and realize consistent performance for its investors.

  • 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

  • SENIOR CRA / CLINICAL PROJECT MANAGER

    DEPARTMENT: Clinical Affairs
    JOB REPORTS TO: Senior Director of Clinical Affairs
    FLSA: Exempt

    POSITION OVERVIEW:

    Working with the Clinical Affairs team in a collaborative and cross functional setting, the Clinical Project Manager will participate as a clinical team member in the management and execution of Phase II – IV cardiovascular medical device trials.

    Essential duties and responsibilities include the following:

    • Provide overall clinical site management from qualification/start-up to closeout.
    • 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 on-site/remote Site Initiation Visits, Interim Monitoring Visits and Closeout Visits according to Monitoring Plan and Data Management Plan; activities to include source document verification, electronic/paper CRF review, protocol and regulatory compliance, device accountability, and visit report writing.
    • Complete study and clinical site status reports, provide ongoing status updates to management.
    • Facilitate clinical site contract and budget process.
    • Develop clinical trial documents and materials.
    • Collaborate with Regulatory Affairs on FDA submissions and international regulatory submissions.
    • Interface with project team, commercial team, external vendors (e.g., data management CRO, core lab).
    • Process and track site payments per approved budget.
    • Verify proper device shipment, accountability and disposition.
    • Conduct internal audits.
    • Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, GCP Guidelines, and ISO standards (as applicable)

     

    REQUIREMENTS:

    • BS or higher in biology, health, medical or clinical sciences (e.g., Physiology or Nursing).
    • 4 – 8+ years clinical research experience in a medical device (preferred) or CRO setting. Monitoring experience required, including one of more years of independent monitoring of medical device trials.
    • Previous experience in a Phase II or III clinical trial and cardiovascular experience 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 on multiple projects in fast paced, dynamic setting.
    • Excellent interpersonal, organizational, and critical thinking skills.
    • Strong written, verbal, and presentation skills.
    • Positive, self-motivated, creative, detailed, and solutions-oriented with the ability to work independently as well as collaboratively in a team environment.
    • Positive, self-motivated, creative, detailed, and solutions-oriented with the ability to work independently as well as collaboratively in a team environment.
    • Travel: currently 10-20%.

     

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

  • SUPPLY CHAIN ASSOCIATE – PLANNER

    DEPARTMENT: Operations
    JOB REPORTS TO: Senior Supply Chain Manager
    FLSA: Exempt

    POSITION OVERVIEW:

    The Planner position effectively schedules, plans and implements work for all products in support of the revenue plan and new product development, ensuring parts or materials are available for Operations to perform the work; plans engineering changes affecting Operations and Supply Chain and coordinates into production when appropriate; coordinates the build plan forecast with the demand plan to identify requirements, highlight differences, and propose solutions; works with other departments  to resolve issues related to materials and production; works with order entry and logistics to schedule and execute shipments; and maintains the EPR system for bills of material, routings, assembly lead times and standard labor hours.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    • Makes decisions to release, firm, cancel, or defer work based upon current inventory, demand, capacity, and material availability.
    • Coordinates with Purchasing to identify existing and potential shortages, develop options for resolution, and communicate status to management.
    • Plans and releases work orders for production, working with inventory control to make sure kits are delivered in a timely manner for production.
    • Coordinates with production to prioritize build activity in the clean room, ensuring the proper mix of product starts and output.
    • Responsible for maintaining appropriate inventory levels of subassemblies and finished goods.
    • Plans engineering changes to ensure ECN instructions are clear and complied with; works with production and purchasing to stop procurement of material affected by change, keeps designated engineers informed of ECN implementation status; coordinates proper rotation of inventory to minimize scrap/reworked parts during implementation.
    • Collaborates with sales order entry and logistics personnel to schedule shipment of customer orders for product, ensuring complete documentation, timely shipment, and communication with the customer.
    • Proposes, gains approval for, and leads implementation of improved planning methods, tools, and reports.

     

    REQUIREMENTS:

    • B.S. degree or equivalent in business administration, supply chain management, or operations management. Additional experience or advanced training in planning techniques may substitute for education requirements.
    • 5 or more years’ experience in a master scheduling, production planning role, preferably in a medical device or other regulated manufacturing environment.
    • Excellent understanding and experience with scheduling and planning methods, product structuring, bills of material, shop floor management, and ERP systems. Experience with Epicor ERP preferred.
    • Excellent communication skills, both written and oral.
    • Strong analytical and organizational skills.
    • Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

     

    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: hr@cardiofocus.com

  • QUALITY ASSURANCE SPECIALIST – COMPLAINTS

    DEPARTMENT: Quality Assurance
    JOB REPORTS TO: Quality Manager / Director of Quality
    FLSA: Exempt

    POSITION OVERVIEW:

    The Quality Assurance Specialist – Complaints shall be responsible for the following activities/job functions:

    • Maintain complaint system including vigilance reportability determination. Investigate complaint returns to attempt to confirm reported complaints. Determine root cause of confirmed complaints, and work with other functions at CardioFocus to determine and implement corrective actions.
    • 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.
    • Assist in implementing and maintaining the quality management system, including corrective and preventive actions, calibration, preventive maintenance, and internal and external quality audits.
    • Support QA department and the company with internal or supplier Quality System audits.
    • Other activities as directed to support the Company’s quality goals and objectives.

    MINIMUM QUALIFICATIONS:

    Undergraduate college degree in an engineering discipline preferred, 0-2 years of work experience, or a combination of education and work experience.

    SKILLS AND ABILITIES REQUIRED:

    • 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
    • Basic knowledge of statistics and statistical techniques
    • Basic knowledge of quality planning, data collection, and charting

     

    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: hr@cardiofocus.com

  • FIELD SERVICE ENGINEER

    DEPARTMENT: Operations
    JOB REPORTS TO: Global Service Manager
    FLSA: Exempt

    POSITION OVERVIEW:

    The Field Service Engineer is responsible for carrying out field service activities including but limited to installations, repairs, and preventative maintenance of capital equipment with associated documentation tasks related to servicing activities.  Additionally, the role will assist with Technical Support account management, console base database record keeping, DHR’s and various service activities as assigned.

     

    RESPONSIBILITIES:

    • Responsible for Installations, Repairs, and Preventative Maintenance of capital equipment for internal and external customers.
    • Verify documents, update, and file on timely basis for all servicing activities performed on equipment. Resolve any discrepancies as needed.
    • Coordinate service visits including scheduling, planning, performing assigned tasks, returning replaced parts if any, completing all documentation, updating the equipment DHR, and sending a final report to customers. The Field Service Engineer will work closely with Sales, Marketing, Operations, QA, Manufacturing, and R&D.
    • Interact with Vendors, Distributors, and Customers (internal or external) to address any service needs/issues.
    • Act as liaison between customer and company to convey feedback to QA to enhance console performance and suggest development serviceability improvements for the product.
    • Assist with assembling, troubleshooting equipment, parts orders, designs, and records maintenance.
    • Responsible for technical support email account and acts as the first line of defense.
    • Communicate with vendors regarding parts and expedite outstanding orders.
    • Travel to customer sites domestically and internationally.
    • Assist Global Service Manager with preparing monthly PM schedule and communicate with corresponding sales account managers as per the expected plan.

    QUALIFICATIONS / EXPERIENCE REQUIRED:

    • Bachelor’s Degree in Engineering, Biomedical Engineering is preferred.
    • 3-5 Years of Field Service in highly regulated industries such as Medical or aerospace although Medical capital equipment field service experience is preferred.
    • A valid passport and driving license is must.
    • This position may require 50-75% domestic and international travel including overnight and weekends and be able to travel with a short notice if needed.
    • Knowledge of medical device regulations and experience in maintaining Design History Files is preferred.
    • Proficient in Microsoft Office including intermediate level Excel skills.

    SKILLS AND ABILITIES REQUIRED:

    • Must have excellent problem-solving skills
    • Must have excellent interpersonal relationship and people skills
    • Must have good organizational skills
    • Must be thorough with a high degree of accuracy and attention to detail
    • Must have excellent reading, writing, and communication skills
    • Must be able to work independently with little supervision as well as being a team player
    • Must have excellent problem-solving skills

    PLEASE NOTE:  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this job.

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