Job Description
Our On-Demand Talent Solutions team is seeking a Manufacturing Engineer to join our highly valued client. The ideal candidate combines strong mechanical design skills with hands-on manufacturing experience and a solid understanding of regulated environments.
**South Bay Area Only**
**Client requires direct W-2 employment; Corp-to-Corp arrangements are not permitted for this role.**
Summary: As a Manufacturing Engineer you will contribute to product design through DFM work and collaborate closely with R&D Engineers, factories and external partners, as needed.
Responsibilities:
- Design, develop, and release custom fixtures, assembly aids and inspection/test methods to support verification, and manufacturing of medical devices.
- Create detailed CAD models and fabrication drawings while collaborating with suppliers and contract manufacturers to ensure manufacturability, durability, cost-effectiveness, and successful production deployment.
- Provide on-site and remote support for equipment bring-up, debugging, process stabilization, and root cause analysis while driving DFM/DFA improvements and corrective actions for tooling and process-related issues.
- Develop and execute IQ/OQ/PQ validation protocols, analyze validation data, implement process improvements, and author documentation in compliance with FDA and ISO standards (e.g. ISO13485).
- Partner cross-functionally with R&D, Quality, and Supplier Quality teams to support design transfer readiness, technical reviews, and quality systems documentation including BOMs, DMRs, Routers, Manufacturing Instructions, FMEAs, and ECOs.
Qualifications:
- Bachelor’s degree in Mechanical Engineering or related field.
- 4–7+ years of experience in manufacturing engineering, tooling, or fixture design.
- Experience with catheters is desirable.
- Strong CAD experience (e.g., SolidWorks) and hands-on expertise in tooling and process validation (IQ/OQ/PQ).
- Working knowledge of ISO 13485, 21 CFR Part 820, and statistical methodologies including DOE and process capability analysis.