Senior/Staff R&D Engineer

Woburn, Massachusetts | Engineering

Senior or Staff R&D Engineer, Implants

 

Our client is a med device start-up looking for some exceptional engineering talent. We have worked with them for several years in various situations and they have been successful with every Structural Heart product they’ve developed.

 

Because it’s a start-up the responsibilities will be broad-based. This means that the payoff is the exposure to the breadth of the business. You will be responsible for the development, testing and manufacturing oversight of the implantable. The work is heavily focused on engineering and scientific principles, the collection and analysis of data, interpretation of those data and recommending actions on the results.

 

Responsibilities:

  1. Ongoing development of implant designs and delivery systems including CAD modeling, documentation, test methods and protocols, and the creation of pilot manufacturing processes
  2. Facilitates production and testing through the design, development and implementation of associated tooling and equipment for manufacturing and assembly processes
  3. Ensures manufacturability, quality and reliability, championing the analysis and evaluation of the data collected for the design intent
  4. Is the lead for the transfer of production from the prototype/pre-clinical/clinical stage of fabrication to full-scale production
  5. Supports the hiring of the R&D team and manages DR’s as needed
  6. Identifies and manages suppliers to ensure consistent, repeatable quality including supply chain management for materials used in the implants
  7. Makes certain that providers of supportive testing (e.g. FEA, cyclic fatigue and hydrodynamic testing) meet quality and on-time delivery expectations
  8. Maintains safety as their highest concern and is immediately responsive to safety related issues
  9. Leads the preparation, execution, analysis and troubleshooting of pre-clinical animal and cadaver studies
  10. Participates in clinical cases
  11. Maintains the DHF, Design Control and Risk Analysis files as required by the QMS
  12. Identifies the inventive aspects of the design, coordinating with counsel as regards IP protection, and participates in patent prosecution

Requirements:

  • BS in Engineering or equivalent technical discipline
  • 7+ years of device experience in the design of products for the structural heart
  • Specific experience in design/testing of pericardial tissue valves with implantable NiTi frames (or other cardiovascular implantable products) highly valued
  • Demonstrable talent in an environment demanding individual contributor and team skills
  • Illustrative experience in the use of CAD; SolidWorks or OnShape
  • Understands and embraces Design Control
  • A passion for the medical device space and the excitement of a start-up
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