Senior Product Development Engineer
1 day ago
Spectra Medical Devices LLC. is seeking a highly skilled Senior Product Engineer to lead the development of innovative medical devices. The ideal candidate will have a strong background in product development, engineering, and regulatory compliance.
The Senior Product Engineer will be responsible for leading design and development documentation, project management, and technical documentation for regulatory files. They will also collaborate with cross-functional teams to ensure compliance with medical device regulations and standards.
Key Responsibilities:
- Lead projects from conceptualization to design transfer
- Develop and maintain design files and project management plans
- Collaborate with regulatory staff to ensure compliance with medical device regulations
- Manage technical documentation for regulatory files
- Support engineering efforts for manufacturing equipment design and development
Requirements:
- BS degree in Engineering
- Minimum of 5 years of relevant experience
- Strong knowledge of medical device regulations and standards
- Excellent organizational and communication skills
About Spectra Medical Devices LLC.
Spectra Medical Devices LLC. 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 committed to delivering innovative medical devices that meet the highest standards of quality and safety.
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