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Kelly Science, Engineering, Technology & Telecom · 3 weeks ago

Manufacturing Engineer (Design Verification)

Irvine, CA

Full-time

Onsite

Mid Level

$45/hr - $55/hr

Kelly Science, Engineering, Technology & Telecom is seeking a Manufacturing Engineer to develop and improve manufacturing processes in accordance with product specifications and quality standards. The role involves coordinating the manufacturing launch of new products, providing mentorship, and leading projects.

Staffing & Recruiting

No H1B

Hiring Manager

Deanna Saulsbury

Responsibilities

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 reductions initiatives

Train employees on current and new manufacturing processes

Qualification

Medical device manufacturingISO requirementsFDA regulationsSolidworksTechnical documentationProcess validationCost reduction initiativesCommunication skills

Required

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