Product Design Engineer- Catheters, Medical Devices
near Wilmington DE

Sr. R&D Engineer - Medical Devices

Global Leader in the development and production of medical devices seeks R&D Engineers for concept generation, design and development of coronary and peripheral catheters.  The Sr. R&D Engineer will:

• Create program plans
• Develop  and maintain Design History Files
• Create and lead cross functional teams
• Develop and validate test methods
• Create design verification and validation testing
• Lead process transfer from R&D to manufacturing

• BS in chemical engineering or polymer engineering, or materials engineering strongly preferred.  Other engineering degrees considered with applicable experience
• 5+ years experience in medical device R&D, preferably with strong polymer or plastics development
• Hands on experience with manufacturing processes involving polymers and polymer products, ie. extrusion, lamination, injection molding, assembly and bonding
• Experience with particulate analysis based on USP 788
• Hands on experience with chemical analysis and lab testing equipment, such as microscopy, polymer characteriztion, chemical analysis and mechanical testing a plus
• Experience leading cross functional teams from concept through product launch
• A solid understanding of FDA requirements and experience with 510(k) and or IDE/PMA submissions
• Candidates should submit resumes in WORD.

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