Manufacturing Engineer; Design Verification

Senior Engineering Recruiter | Powering tomorrow’s innovations with today’s brightest engineering talent

Manufacturing Engineer

• Contract Duration: 12 months – Estimated to end: 12/2026 (Contract Extension possibilities and internal hire potential)
• Location: 100% ONSITE - Irvine, CA (94538)
• Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer. Sponsorship is NOT available NOW or in the FUTURE for this role.
• Pay: Negotiable depending on direct-related experience up to $45 - $55 an hour

Develops, implements, and improves manufacturing processes in accordance with product specifications and quality standards. Recommend and implement improvements to production processes, methods, and controls. Coordinates manufacturing launch of new or revised products. Provides mentorship to others on team. Expected to be a Project Leader.

• Tooling design and process development.
• Ensure product and process quality by designing test methods, testing finished products and performing process capabilities studies.
• Create and approve product drawings and documents.
• Establish and perform verification and validation activities including design verification testing, process and packaging validation and shelf-life studies.
• Prepare product and process reports by collecting, analyzing and summarizing test data.
• Evaluate and solve production problems.
• Represent manufacturing in cross‑functional meetings.
• Ensure new equipment and tooling meet process validation requirements per established guiding procedures.
• Target and implement cost reduction initiatives.
• Train employees on current and new manufacturing processes.

• Reading and preparing technical documentation.
• Working knowledge of standard machine shop equipment and processes.
• Expertise with medical device manufacturing equipment and processes.
• Understanding of medical and technical development.
• Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale‑up processes.
• Computer skills including Word, Excel and Solidworks.
• Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams both verbally and in writing.

Important information:
To be immediately considered, please send an updated version of your resume to

*** (Kelly does not expense relocation/interview costs)

Associate

Full‑time

Engineering, Production, and Manufacturing

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing