Senior to Principal Manufacturing Process Engineer

Cambridge Recruiters; Irvine (CA); Presencial; USD 120.000 - 190.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Root-cause analysis

Cross-functional

DOE

Process characterization

Troubleshooting

Statistical techniques

Team leadership

Mechanical design

Educación

Bachelors in Mechanical Eng

Herramientas

SolidWorks

Descripción del empleo

Process Development Engineer (Title Flexible: Senior to Principal, or hands-on Manager)

Location: Irvine, CA

About the Role

As a Process Development Engineer, you will develop, validate, and industrialize the manufacturing processes for catheter and clot-retriever products. This is a hands-on, manufacturing-engineering-centric role: you will build and optimize processes, design tooling and fixtures, execute process validations (IQ/OQ/PQ), and drive manufacturing readiness both in-house and at external partners. You will work in close partnership with Product Development, Quality, and Operations to scale new devices from pilot builds to commercial production.

What You Will Do

• Develop, optimize, validate, and scale manufacturing processes for catheter- and Nitinol stent-based clot-retrieval devices, from new product introduction (NPI) through commercial production.
• Provide process leadership for catheter assembly operations such as shaft assembly, reflow, thermal and adhesive bonding, braiding/coiling, lamination, heat-shrink, tip forming, coatings, and precision assembly.
• Design, procure, and qualify tooling, fixtures, and manufacturing equipment in compliance with applicable requirements.
• Plan and execute process characterization studies, Design of Experiments (DOE), and statistical analyses to establish process capability, critical parameters, and operating windows.
• Lead equipment and process qualification and validation activities (IQ, OQ, PQ, Gage R&R, Cp/Cpk).
• Author and maintain manufacturing documentation: process flows, work instructions, equipment specifications, validation protocols/reports, and pFMEAs.
• Drive Design for Manufacturability (DFM) feedback into product design during development.
• Troubleshoot and resolve manufacturing issues affecting safety, quality, yield, throughput, and cost using structured root-cause methodologies.
• Lead technology transfer and scale-up activities in-house and to external suppliers/contract manufacturers.
• Drive continuous improvement in yield, cycle time, and process capability.
• Train and provide technical guidance to operators, technicians, and junior engineers (scope scales with level).
• Support risk management, CAPA, and audit activities in a compliant manner.

Requirements

• Education: Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering discipline (Master’s a plus).
• Experience: 5+ years of medical device manufacturing/process engineering experience (Senior); 8+ years (Staff); 10+ years with demonstrated technical leadership (Principal).
• Proven experience in manufacturing operations for Class II and/or Class III devices.
• Strong troubleshooting, root-cause analysis, and cross-functional collaboration skills.
• Hands-on experience with process characterization, and process validation.
• Experience designing tooling and fixtures, and interpreting engineering drawings (SolidWorks preferred).
• Basic understanding of statistical techniques.

Preferred Qualifications

• Direct experience with catheter or minimally invasive device manufacturing (extrusion, reflow, braiding, thermal/adhesive bonding, laser processing, coatings, automated assembly, packaging).
• Experience working with external suppliers or contract manufacturers.
• Knowledge of FDA QSR (21 CFR 820), ISO 13485, and GMP.
• Experience in a start-up or fast-paced, resource-constrained environment.

Level & Compensation

This role is open at the Senior, Staff, Principal, or Manager level. Title, scope, and compensation will be calibrated to the successful candidate’s experience and demonstrated technical leadership.

Additional Notes

• On-Site position (not remote or hybrid)
• Local Candidates strongly preferred
• Must have US Work Authorization or be a US Citizen. No Sponsorships or Visa Transfers