What are the responsibilities and job description for the Manufacturing Engineer position at Advanced Clinical?
Job Title : Manufacturing Engineer - Medical Device
Location : Fremont, CA area - On-site (5 days / week)
Start Date : March 2
Duration : Through 2025 (with potential for extension)
About the Role :
Our client, a global medical device company, is seeking a Manufacturing Engineer to support audit readiness, process validation, and manufacturing improvements . The ideal candidate will conduct gap assessments, update documentation, develop process PFMEAs, and execute validation activities (IQ / OQ / PQ) while ensuring compliance with regulatory standards.
Key Responsibilities :
- Lead audit readiness activities, including gap assessments and documentation updates.
- Develop and execute process validation protocols (IQ / OQ / PQ) and support PFMEA development.
- Ensure compliance with FDA, ISO, and other regulatory requirements through process improvements.
- Provide data analysis and manufacturing line support to enhance efficiency and quality.
- Collaborate with Quality Engineering (QE) and cross-functional teams to drive process optimization.
Qualifications :
