Senior Product Engineer

3 days ago


Wilmington, Delaware, United States Spectra Medical Full time
About the Job

Spectra Medical Devices is a leading manufacturer of made-to-spec procedural needles and a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies. We are seeking a Senior Product Engineer to join our team.

Key Responsibilities
  • Lead projects using project management techniques, from conceptualization to design transfer.
  • Develop and implement design and development documentation under Design Control requirements.
  • Manage technical aspects of business, including CAPAs, regulatory filings, and root cause identification.
  • Collaborate with regulatory staff to evaluate product compliance to applicable regulations and project requirements.
  • Support sales and marketing at technical tradeshows and may include travel within the US.
Requirements
  • BS degree in Engineering.
  • Minimum of 5 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.
  • BS degree preferably in mechanical engineering, manufacturing engineering, or bio-medical engineering.
  • 8+ years product design and development experience in a manufacturing or industrial environment, preferably in an FDA regulated environment.


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