Careers

  • QUALITY SPECIALIST / ANALYST

    Job Title:                  Quality Specialist / Analyst                                

    Department:             Quality Assurance    

    Job Reports To:       Quality Manager / Director of Quality & Regulatory Compliance

    FLSA:                         Exempt / Exempt

     

    Position Overview:

    The Quality Specialist / Analyst performs the following:

    • Performs product release activities including review of DHRs, sterilization records and post-production release documents.
    • Creates, controls and maintains training documents and document files.
    • Support and conduct New Employee training and provides training support, as applicable.
    • Collect training records, checks for accuracy, completeness, and obtains corrections when necessary.
    • Reviewing all types of documentation for completeness and accuracy. This includes manufacturing assembly, data calculation and log entries, supplier documents and test documents.
    • Develop and implement quality data reporting and analysis function to support the overall Quality Management System.
    • Provides critical information for audits and reviews/analyzes data and documentation.
    • Coordinates and conducts technical investigation and documentation of non-confirming events and corrective/preventative action.
    • Identify and address any potential quality impact.

     
    Minimum Qualifications:

    • Bachelor’s degree (B.S.) or equivalent in related field.
    • 2-3 years related experience in an FDA QSR, cGMP, ISO 13485 compliant environment.
    • Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Production Controls.
    • Prior medical device experience, highly desirable.
    • Experience in a manufacturing facility preferred.
    • Detail-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player.
    • Proven problem-solving skills.
    • Must be able to interpret variety of technical instructions.
    • Advanced skills in Word, Excel and other MS Office applications.

     
    Essential Duties and Responsibilities include the following:

    • Knowledge of FDA Quality System Regulation, cGMP and Iso 13485: 2016, as they pertain to medical device industry.
    • Performs product release activities including review of DHRs, sterilization records and post-production release documents.
    • Review Quality and Operations key performance indicators and support the compliance effort of the Quality team.
    • Creates, controls and maintains training documents and document files.
    • Support and conduct New Employee training and provides training support, as applicable.
    • Collect training records, checks for accuracy, completeness, and obtains corrections when necessary.
    • Reviewing all types of documentation for completeness and accuracy. This includes manufacturing assembly, data calculation and log entries, supplier documents and test documents.
    • Develop and implement quality data reporting and analysis function to support the overall Quality Management System.
    • Provides critical information for audits and reviews/analyzes data and documentation.
    • Coordinates and conducts technical investigation and documentation of non-conforming events and corrective/preventative action.
    • Identify and address any potential quality impact.

     
    Skills and Abilities Required:

    The above information (essential duties and responsibilities) 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.

    Physical Demands:

    Normal day to day responsibilities in a production cleanroom and office environment with routine sitting and standing.

    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

  • MANAGER OF SUPPLY CHAIN

    Job Title:                   Manager of Supply Chain

    Department:             Operations

    Job Reports To:       Vice President – Operations

    FLSA:                         Exempt

     

    Position Overview:

    This is a hands-on position where in addition to daily oversite and direction of a team that includes purchasing, planning, inventory control and shipping & receiving, the Manager will be actively involved in sourcing and supplier management, capacity analysis, inventory planning, safety stock calculation, communication with Sales team regarding stock availability and system reporting. The person in this position will play a major role in the overall success of the Operations Team with the goal of creating exceptional customer service. He/she will be responsible for use and accuracy the of ERP system and demand forecasting models to ensure on-time availability of all manufacturing supplies and components, also driving efforts to significantly improve physical inventory management practices and accuracy. This position interfaces regularly with representatives from Manufacturing, Quality, Finance, Sales and Marketing.
     
    Responsibilities::

    • Developing, supporting, and monitoring departmental objectives towards the goal of achieving the annual Company Operating Plan.
    • Utilizing Epicor ERP system to manage the following:
    • o Parts status and inventory accuracy
      o Manufacturing activities (including scheduling and releasing work orders)
      o Resource planning
      o Bills of Material and costing information
      o S&OP

    • Managing Inventory levels to minimize production risk while maximizing inventory turns.
    • Identifying and driving adoption of Key Performance Indicators as they apply to Supply Chain success, as well as providing input to KPIs as they apply to Manufacturing success.
    • Preparing materials and facilitating monthly S&OP cross functional meeting.
    • Management of supplier relationships to ensure efficient use of resources and effective material and component supply practices.
    • Monitoring open Purchase Orders and Stock Status reports and expediting order fulfillment to ensure on time delivery.
    • Arranging International shipments and verifying accuracy of all documentation.
    • Maintaining strong relationships and communications with European warehousing and distribution partners..
    • Communication with internal/external commercial teams to support inventory replenishment needs.
    • Oversite and maintenance of physical inventory system, including ERP transaction accuracy, physical inventory events, and cycle counting.
    • Filling in for departmental functons during vacations or absences.
    • Other projects, assignments, and duties as required.

     
    Core Competencies:

    • Management skill proven experience managing a Supply Chain team.
    • Solid knowledge of Supply Chain and Materials Management Systems.
    • Ability to prioritize departmental activities set effective (SMART) goals and objectives in line with overall corporate strategy.
    • Ability to interpret data and make decisions, including appropriate personnel where needed. Exhibit sound and accurate judgment.
    • Ability to forge positive relationships and communicate effectively with all levels of management and with all departments.
    • Ability to proactively manage suppliers and develop Strategic relationships where needed.
    • Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.

     
    Minimum Qualifications:

    • Bachelor’s Degree or equivalent experience, preferably in Business or a supply Chain related field.
    • Three to five years of Supply Chain Operational experience in Medical Device industry with in-house manufacturing.
    • Two to five years Supervisory Experience.
    • Association membership (APICS or other) preferred.
    • Strong ERP system experience.
    • ERP System implementation a plus.
    • Must speak and understand English proficiently.

     
    Physical Demands:

    While performing the duties of this job, the employee is regularly required to be at a desk or 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, and work at a computer for long periods at a time. Must have the ability to lift/move/carry for short distances materials weighing up to 25 lbs. No specific vision requirements.

     
    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 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

  • 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