Product Development Engineer

Analysis, CAD, Development, Excel, FDA, FEA, ISO, Materials, Medical Device, Microsoft Project, MS Office, PowerPoint, Project, Validation
Full Time
Work from home not available Travel required to 10%.

Job Description


JOB DESCRIPTION






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)





Please send resume to Derek Herbine: dherbine@pipercompanies.com

Dice Id : 10430981
Position Id : 25026
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