R&D Engineer

Job Role: 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. Primary Skills: Knowledge on ISO 13485, FDA 21 CFR part 820, Risk Management - ISO14971. Should have prior new product development experience in medical device systems. Experience in IQ,OQ,PQ of components and process validation. Experience in Developing process controls, PFMEA documents and in process and release test methods. Stake holder management, Conducting review meetings.