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.

RESPONSIBILITIES:

• 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

REQUIREMENTS:

1. Bachelor’s Degree in an Engineering discipline, prefer Mechanical or Biomechanical
2. 4-6 years of experience in medical device engineering and research and development environment, preferably with small to mid-size companies
3. Proficiency in solid CAD modeling (SolidWorks or equivalent)
4. Knowledge of FDA 21 CFR Part 820 and ISO 13485 preferred
5. Experience with FEA software and methods is a plus
6. Must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines
7. Strong hands-on and craftsmanship skills are strongly desirable for this position
8. Experience with stage-gating, project management and tools like MS Project a plus