Manufacturing Engineer

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:

• Bachelor's degree preferred in Manufacturing Engineering, Mechanical Engineering, or a related field.
• Minitab experience required for statistical analysis and process validation.
• 4 Years Experience in medical device manufacturing and regulatory compliance preferred.
• Strong problem-solving and hands-on troubleshooting skills in a fast-paced environment.