Manufacturing Sustaining Engineer

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 [email protected]

Pay: $65,000.00 - $85,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Work Location: In person