Applying for: Product Development Engineer – Cardiology

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Current Vacancies

Product Development Engineer – Cardiology

Product Development Engineer – Cardiology

 

JOB DUTIES

  • As part of the R&D organization responsible for the design of cardiology devices, this includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, regulatory approvals, product introduction, and post-market surveillance
  • Obtain market feedback from cardiac surgeons and other customers to determine functional and design specifications for new product development
  • Design and develop instruments and implants using CAD software
  • Create and maintain project plans and project documentation (e.g. DHF, DMR) for the projects involved, adhering to the design controls within the New Product Development Process
  • Manage all aspects of the project to ensure timely completion of tasks while remaining in full compliance with regulatory requirements/ quality systems
  • Perform design verification and validation activities to ensure designs meet specifications
  • Assist in the writing of regulatory applications (CE mark, FDA clearance)
  • Collaborate with Supply Chain and outside vendors for prototyping and for the preparation of the design transfer/setup of manufacturing
  • Participate in product introductions through sales training, customer calls/visits, etc.

 

REQUIRED QUALIFICATIONS

 

  • Engineering degree with minimum 3-5 years industrial work experience in the area of product development/sustaining engineering of cardiac devices, a solid understanding of the regulatory environment for medical devices (e.g. ISO 13485, EU-MDR, FDA QSRs, Risk Management)
  • Solid knowledge of CAD for modeling and design of implant components, including tolerance analysis, understanding of main manufacturing processes involved in the manufacturing of orthopedic/spinal implant systems or alike
  • Strong experience in project management (project planning, monitoring, reporting, issue handling), multi-tasking abilities required for successful job completion
  • Strong communication skills to coordinate work items, address potential conflicts in an early, respectful and responsive manner

Job Reference:

Life Sciences & Medical

Pennsylvania