Manufacturing Sustaining Engineer Dynaflex Technologies Irvine, CA Job Details Full-time $65,000 - $85,000 a year 8 hours ago Benefits Health insurance Dental insurance Paid time off Qualifications Defect resolution root cause analysis Manufacturing facility experience Medical device manufacturing facility experience Industrial engineering Quality control problem-solving Regulatory/legal compliance standards in production Quality standards in production Biomedical regulatory compliance Quality audits Biomedical manufacturing processes Root cause analysis Process engineering

ISO 13485 FDA

regulations Full Job Description DynaFlex Technologies Manufacturing / Sustaining Engineer —

Medical Device Location:

Irvine, CA (On-site)

Compensation:

$65,000 - $85,000 (based on experience) About DynaFlex DynaFlex is a U.S.-based medical device contract manufacturer specializing in advanced catheter technologies. We partner with leading med-tech companies to design, develop, and manufacture precision-engineered products that improve patient outcomes. About the Role This is a hands-on, high-impact engineering role combining manufacturing execution and product sustaining. You will work directly on the production floor while also supporting product quality, design changes, and regulatory compliance. Key Responsibilities Support catheter manufacturing processes (extrusion, reflow, assembly) Troubleshoot production issues and implement real-time solutions Improve yield, reduce scrap, and optimize line efficiency Lead root cause investigations (CAPA, nonconformance, complaints) Execute engineering changes (ECOs / DCRs) Support validation activities (IQ/OQ/PQ) Maintain DHF, DMR, and manufacturing documentation Support audits and regulatory compliance (FDA, ISO 13485)

Qualifications Required:

2-3 years experience in medical device manufacturing Hands-on production floor experience Strong problem-solving skills (5 Whys, 8D) Familiarity with

FDA 21 CFR

Part 820 and

ISO 13485

Engineering degree (Mechanical, Biomedical, Materials, or related)

Preferred:

Catheter or minimally invasive device experience Materials experience (PEBA, nylon, polyurethane) Process validation (IQ/OQ/PQ) CAD (SolidWorks or similar) Lean / Six Sigma exposure Work Environment On-site in Irvine, CA. Cleanroom and manufacturing floor exposure. Standard hours with flexibility during production or quality events.

Inquiries Pay:

$65,000.00 - $85,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off

Work Location:

In person