Sr. Product Development Engineer
Our client is a late-stage med device start-up with a novel technology addressing unmet surgical needs with a full development pipeline, and generating revenue from predecessor products. The bonus is that this is a group of people who have successfully introduced other new products to med device so their knowledge of what it takes to achieve results is unmatched.
The individual must have a 4 year degree in engineering, and 4-6 years’ experience in Medical Device development. Other critical experience includes Design Control, hands-on experience with product design beyond simply building a drawing, and a good understanding of how to develop/implement test methods. You will work cross-functionally to ensure documentation is compliant to the needs of ISO 13485, 21 CFR 820, and FDA regulations; participate in Risk Analysis, Data Collection/Analysis, Controls & Procedures.
Why should you be interested? Because the product is exciting, the company is growing rapidly, and there is a lot of career growth runway in front of the right candidate.
- Creates and keeps current the Design Control documentation for the project
- Key participant in the development of new products and/or line extensions
- Evaluates new concepts, directs prototyping and resolves complex problems with proven engineering principles like DOE, FEA, SPC, and including FMEA
- Creates in-depth protocols to test/analyze and demonstrate alignment to inputs/outputs
- Ensures durable and reliable test methods, designs and has built test fixtures to include tolerance stack-ups; executes measurement system analysis
- Defines and/or performs benchtop studies for design verification, root-cause-analysis and/or troubleshooting to evaluate product performance
- Works with Quality to perform SPC based data analysis presenting reports and recommendations to peers and management
- Facilitates the needs of Design Control as it relates to change in material, design, or process; ensuring thorough documentation and research analysis records
- Will be involved in and/or lead both technical and design reviews
- Understands the application of GD&T principles to specifications
- Bachelor’s Degree in an Engineering discipline, prefer Mechanical or Biomechanical
- 4-6 years of experience in medical device engineering and research and development environment, preferably with small to mid-size companies
- Proficiency in solid CAD modeling (SolidWorks or equivalent)
- Knowledge of FDA 21 CFR Part 820 and ISO 13485 preferred
- Experience with FEA software and methods is a plus
- Must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines
- Strong hands-on and craftsmanship skills are strongly desirable for this position
- Experience with stage-gating, project management and tools like MS Project a plus