Senior Product Development Engineer
Product Development in Medical Device is probably the most exciting place an engineer can work but when combined with a start-up you are 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. In a start-up, you’re not pigeonholed into a single responsibility leaving you to wonder exactly what your efforts contributed to the product’s success or failure.
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 the chance to have a positive impact of patients’ lives.
Not afraid of a hands-on role where you may 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 a start-up? We’ve got a position you want to hear more about.
- 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
- Leads 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; generates design assurance documents required for the DHF
- Manages, in conjunction with guidance by the QS, the DHF
- Centrally responsible for project Timeline and Budget management
- Works with Quality to develop QC procedures and inspection methods (i.e. Quality Plan)
- Technical liaison to marketing to develop accurately represented collateral
- Works closely with RA to support 510(K) submissions
- Works with manufacturing engineering to develop Process and ECO’s as required
- 4 year degree in Mechanical or Biomedical engineering (Master’s a plus) with 5-10 years’ experience in medical device product development (orthopedic strongly preferred)
- Must be a SolidWorks expert including 3-D surfaces, design table configurations and GD&T
- Demonstrable strength with FEA using Ansys; in-depth understanding of its application and outputs
- Well versed in the demands of 21CFR820 (cGMP’s), ISO 13485; especially Design Control
- Responsible for project stage-gating, milestone definition/decision-making and time management
- Demonstrable cross-functional development experience including planning, leading and reporting
- Strong anatomical experience (prefer joints, primary or peripheral; knee experience a huge plus)
- Experienced in manufacturing including machining, forging, casting and other methods (e.g. Additive manufacturing) employed by vendors including expertise in DFM
- Highly effective written and verbal communications skills, comfortable interacting with Senior Management as well as with Surgeon Panels, Sales & Marketing and VOC groups; comfortable leading and working with other technical staff
- In-depth experience with engineering tools like FMEA’s, V&V reports, DOE and others especially as required in documentation for certified bodies (e.g. FDA, BSi, TUV, Shonin, etc.)