Senior Principal Medical Device Process Engineer – Manufacturing Lead

Cambridge Recruiters; Irvine (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Cambridge Recruiters seeks a Process Development Engineer in Irvine, CA to develop, validate, and industrialize manufacturing processes for catheter and clot-retriever devices. This hands-on role emphasizes process optimization, tooling design, and robust IQ/OQ/PQ testing to scale pilot builds to commercial production.

You will lead process characterization studies, DOE, and CPk analyses, supervise equipment qualification, and collaborate with Product Development, Quality, and Operations.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering.
• 5+ years of medical device manufacturing/process engineering experience (Senior); 8+ years (Staff); 10+ years with demonstrated technical leadership (Principal).
• Experience in manufacturing operations for Class II and/or Class III devices; design tooling and fixtures; interpret engineering drawings.

Responsibilities

• Develop, optimize, validate, and scale manufacturing processes for catheter- and Nitinol stent-based devices from NPI to production.
• Provide process leadership for catheter assembly operations (shaft assembly, reflow, bonding, braiding, lamination, coatings).
• Design, procure, and qualify tooling, fixtures, and manufacturing equipment to meet requirements.

Skills

Root-cause analysis

Cross-functional

DOE

Process characterization

Troubleshooting

Statistical techniques

Team leadership

Mechanical design

Education

Bachelors in Mechanical Eng

Tools

SolidWorks

Job description

Cambridge Recruiters seeks a Process Development Engineer in Irvine, CA to develop, validate, and industrialize manufacturing processes for catheter and clot-retriever devices. This hands-on role emphasizes process optimization, tooling design, and robust IQ/OQ/PQ testing to scale pilot builds to commercial production.

You will lead process characterization studies, DOE, and CPk analyses, supervise equipment qualification, and collaborate with Product Development, Quality, and Operations.