Senior or Staff Product Development Engineer

Reference Number: 460
Location: NJ

Senior and/or Staff Product Development Engineer

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 a hands-on role where you’ll be mentoring and coaching almost as much as doing?  Not afraid of being out in front of the team, of being the one that management depends on for the right information?  Not afraid of working in a start-up?  We’ve got a position you want to hear more about. 

RESPONSIBILITIES: 

  • Guided by every principle of Design Control and the company’s QS the incumbent will Design, Develop and Document Class II devices, their instruments and sterilization procedures
  • A highly ethical and accountable leader of cross-functional teams responsible for NPD from Concept to Commercialization; responsible for effectiveness and velocity of the project
  • Lead the conversion of Concept to working prototypes including protocols for testing and data analysis, generating technical reports pursuant to test results and data analyses
  • Pursuant to the requirements of Design Control; generate design assurance documents required for the DHF
  • Manage, in conjunction with guidance by the QS, the DHF
  • Centrally responsible for project Timeline and Budget management
  • Work with Quality to develop QC procedures and inspection methods (i.e. Quality Plan)
  • Technical liaison to marketing to develop accurately represented collateral
  • Work closely with RA to support 510(K) submissions
  • Work with manufacturing engineering to develop Process and ECO’s as required

REQUIREMENTS: 

  1. 4 year degree in Mechanical or Biomedical engineering (Master’s a plus) with 8-12 years’ experience in orthopedic product development, 3-5 years of which is in knees 
  2. Must be a SolidWorks expert including 3-D surfaces, design table configurations and GD&T
  3. Demonstrable strength with FEA using Ansys; in-depth understanding of its application and outputs
  4. In tandem with Design Control expertise; responsible for project stage-gating, milestone definition/decision-making and time management
  5. Demonstrable cross-functional development experience including planning, leading and reporting
  6. Strong anatomical experience, especially as pertains to knee and hip joints
  7. Experienced in Orthopedic manufacturing including machining, forging, casting and other methods (e.g. Additive manufacturing) employed by vendors including expertise in DFM
  8. Highly effective written and verbal communications skills, comfortable interacting with Senior Management as well as with Surgeon Panels, Sales & Marketing and VOC groups
  9. In-depth experience with engineering tools like FMEA’s, V&V reports and others especially as required in documentation for certified bodies (e.g. FDA, BSi, TUV, Shonin, etc.)  
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