Piper Companies is looking for a Product Development Engineer to assist with the design and development of medical implants/instrument systems in the orthopedic arena (orthopedic/trauma/foot and ankle with some spine) for a Medical Device Company in King of Prussia, PA.
Responsibilities for the Product Development Engineer include:
- Experience in medical device design principles, material selection, ability to verify and validate design concepts and understand design failure modes
- Understanding of various types of manufacturing, mechanisms, materials, drafting standards and GD&T are required
- Experience with DHF design controls per Medical Device guideline CFR 21 820.30 is required
- Performing detailed and in-depth analysis' of all aspects of design control documentation, including Functional and Design Requirements, Risk Analysis, Verification and Validation activities, Project Planning, and Design Change documentation practices
- Experience with documentation required for US FDA and/or ISO 13485 class I and II medical devices is required
Qualifications for the Product Development Engineer include:
- Bachelor's degree in Engineering or related field
- 4 years of medical device product development required
- Strong Creo/ProEngineer CAD Software experience is required, Creo Simulate FEA Software experience is a plus.
- The ability to effectively communicate with Surgeon facility and other team members is required.
- Strong proficiency operating MS Office Suite (Word, Excel, and PowerPoint) and Microsoft Project are required.
- This position may require up to 10% tri-state area travel.
Compensation for the Product Development Engineer include:
- Hourly Range: $45.67/hour - $52.88/hour ($95,000 - $110,000)