Careers at CardioFocus

  • QUALITY MANAGER

    Job Title:                   Quality Manager

    Department:             Quality Assurance

    Job Reports To:       Director of Quality Assurance & Regulatory Compliance

    FLSA:                         Exempt

     

    Position Overview:

    The Quality Manager oversees quality functions for the company including, but not limited to, Quality Inspection, Process Improvement, Supplier Management, Batch Record Review, reviewing Change Orders, Product and Process Development, and Quality System Improvement. The Quality Manager will train and mentor quality inspectors and supervisor. This position will require direct involvement with daily quality requirements execution. The Quality Manager is also responsible for maintaining compliance to FDA QSR and ISO 13485 requirements for a Class III Medical Device company.

    Minimum Qualifications::

    Requires at a minimum a BS in science or engineering with 5+ years of medical device or life science quality management or quality engineering supporting manufacturing with 1-3 years
    supervisory experience. Experience with US Class III medical devices with cardiac electrophysiology devices a plus.

    Skills and Abilities Required:

    • Demonstrated leadership abilities and the ability to manage a team to achieve company goals.
    • Must collect and organize diverse information to solve problems, guide the organization, and ensure high product quality.
    • Must prioritize and plan work activities, set goals and objectives, and organize and schedule other people and their tasks.
    • Must be able to write clearly and concisely and be able to communicate across different levels of the organization.
    • Strong knowledge of quality engineering concepts and medical device requirements and the ability to train others on these concepts and 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

  • Catheter Development Engineer

    We are seeking a talented, hands-on and enthusiastic catheter engineer with medical device development capabilities.  You would join an R&D team designing the next generation of cardiac ablation systems for treatment of heart arrhythmias.

    This role requires a self-starter who will play a key role in developing robust catheter designs for manufacturability, and bring new products through commercialization.  Responsibilities include ideation and invention, solving unique technical challenges, conducting required benchtop/preclinical testing to prove safety and efficacy, and support of regulatory submissions.  This role requires strong analytical and problem-solving skills and detailed knowledge of the catheter build process. The candidate will need to effectively collaborate with a cross-functional team including engineers and technicians in achieving objectives.

    QUALIFICATIONS

    • BS degree or equivalent experience in engineering or science (MS a plus). Preferred fields: Plastics engineering, Mechanical engineering, Biomedical engineering.
    • 2 or more years of successful experience in the development and commercialization of catheter/disposable devices. Senior engineers are encouraged to apply; salary is commensurate with relevant skills and experience
    • Demonstrated ability to take projects from concept through product realization.
    • Experience developing complex endoscopic, vascular or cardiac catheter systems is a plus.
    • Strong knowledge of catheter fabrication processes required.
    • 3D CAD modelling such as SolidWorks is desired.
    • Good written and verbal communication skills – must be able to write clear reports, specifications, proposals and effectively discuss them with other members of a multi-disciplinary team (R&D, MFG, Quality, Clinical, Marketing)
    • Working knowledge of regulatory requirements for medical devices.
    • Basic understanding of statistics for design applications is desired.
    • Exposure to the development of radio frequency ablation systems or electroporation systems is a plus.

    ABOUT CARDIOFOCUS

    CardioFocus is an innovative medical device company and the world the leader in endoscopically guided laser treatment of atrial fibrillation. CardioFocus offers a collaborative work environment in a growing field.  CardioFocus offers an excellent opportunity to join a technologically rich company on its way to becoming a dominant force in the Atrial Fibrillation Ablation market.

  • ELECTRICAL ENGINEER

    Significant opportunity for an energetic and talented Electrical Engineer with medical device development capabilities including high voltage and high frequency energy delivery systems.  You would report to the Director of R&D and join an expanding developer of innovative systems that have successfully treated thousands with life threatening cardiac arrhythmias.

    This role requires a self-starter who will play a key role developing product concepts and prototypes, and participate in all stages of the design, development, and regulatory approval of new products.  Responsibilities include ideation and invention, solving unique technical challenges, management of suppliers and contract development partners and support of regulatory submissions.  This broad and challenging role requires strong analytical and problem-solving skills and knowledge of electronic hardware and software.  The role will work closely with senior management across CardioFocus functional groups and be a focal point for in-house knowledge of electronic systems.

    QUALIFICATIONS

    • BS or advanced degree in Electrical Engineering, Biomedical Engineering, or related discipline and 2 or more years of successful experience in the medical device industry. Senior engineers are encouraged to apply; salary is commensurate with relevant skills and experience.
    • Demonstrated ability to take projects from concept through product realization.
    • Electronic prototyping, system integration, debug and verification skills desired.
    • Strong understanding of IEC 60601-1, 3.1 edition Safety and Essential performance
    • Knowledge of LabView strongly desired.
    • Ability to effectively manage outsourced product development engineering.
    • Good written and verbal communication skills – must be able to write clear reports, specifications, proposals and effectively discuss them with other members of a multi-disciplinary team (R&D, MFG, Quality, Clinical, Marketing).
    • Working knowledge of regulatory requirements for medical devices.
    • Exposure to the development of radio frequency ablation systems or electroporation systems, and/or complex systems with a catheter component for cardiology or electrophysiology is a plus.

    ABOUT CARDIOFOCUS

    CardioFocus is an innovative medical device company and the world the leader in endoscopically guided laser treatment of atrial fibrillation. CardioFocus offers a collaborative work environment in a growing field.  CardioFocus offers an excellent opportunity to join a technologically rich company on its way to becoming a dominant force in the Atrial Fibrillation Ablation market.

  • 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