Development Engineer, Medical Device

Reference Number: 459
Location: NJ

Development Engineer, Medical Device

Product Development in Medical Device is probably the most exciting place that an engineer can work but when combined with a start-up you’re at excitement’s pinnacle.  In a start-up, you touch every piece of the business adding to your résumé in ways that no other business offers you the chance to do.  In a start-up, you’re not pigeonholed into a single responsibility leaving you to wonder exactly what your efforts did to contribute to the product’s success or failure. 

To the contrary, in this job, you’ll see the impact of your efforts all day, every day.  In this job, today’s efforts will be the tomorrow’s legacy.  In this job you’ll go home at night with a smile on a very tired face because you’ve worked hard but also had a significantly positive impact of patients’ lives. 

Not afraid of your skills being tested every day?  Not afraid of high velocity teams where change is a mantra?  Not afraid of working in a start-up?  We’ve got a position you want to hear more about. 

RESPONSIBILITIES:

  • Guided by the principles of Design Control and the company’s QS you will participate in the Design, Development and Documentation of Class II devices, and their instruments
  • Important participant in cross-functional NPD teams from concept to commercialization
  • Contributes to the team’s needs during prototype development and manufacture for the purpose of design evaluation
  • Through analysis of new and existing products, contributes to the drafting of test protocols to prove design intent
  • Contributes to the DHF (Design History File) by generating design assurance, input/output, and risk analysis documentation 
  • Strictly adheres to QA/QC procedures; may aid in parts inspection; may contribute to Quality planning
  • Creates and processes Engineering Change Orders (ECO’s)

REQUIREMENTS:

  1. Bachelor’s degree in Mechanical or Biomedical Engineering and a minimum of 2-5 years’ experience in the development of Orthopedic devices.
  2. Experienced with 3-D CAD systems where the majority of the experience is with SolidWorks
  3. Education in and some experience with Stage-Gating design control processes
  4. Demonstrable planning, organization and time management skill with the ability to characterize contribution to and success of cross-functional teams
  5. Background in machining, forging, casting and/or general manufacturing methods as well as experience with vendors is a plus
  6. Education in and experience with the use and interpretation of GD&T per ASME Y14-5-2009
  7. Anatomical experience or knowledge, especially as pertains to knee and hip joints a plus
  8. Understanding of DFM as it applies to processes used in the manufacture of Orthopedic implants/instruments
  9. Strong verbal and written communication skills.
  10. Knowledge of and some background in the creation of Design Control documents (e.g. project schedules, FMES’s, V&V reports, and others as required by certifying bodies (e.g. FDA, BSI, TUV, etc.) 
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