Research and Development Engineer
1 week ago
Job Title: R&D Engineer
Location: Lake Forest, CA
Job Description:
The R&D process engineer will liaison between the R&D team and Contract Manufacturing vendors to ensure the process is followed appropriately as per the regulations.
Key Responsibilities:
- Liaise between R&D team and Contract Manufacturing vendors
- Ensure process is followed as per regulations
- Develop process controls, PFMEA documents, and in-process and release test methods
- Conduct stakeholder management and review meetings
Requirements:
- Knowledge on ISO 13485, FDA 21 CFR part 820, and Risk Management - ISO14971
- Prior new product development experience in medical device systems
- Experience in IQ, OQ, PQ of components and process validation
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