Lead, Medical Device Process Development & NPI

Cambridge Recruiters; Redwood City (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

Cambridge Recruiters seeks a Process Development Manager, R&D – Medical Devices in Redwood City, CA, to build and lead the Process Development Engineering function, driving products from development through design transfer, manufacturing validation, and commercialization.

The role requires 10+ years in medical device manufacturing/process development and 3+ years of engineering leadership, with strong ISO 13485, GMP, and FDA knowledge, plus excellent cross-functional communication.

Qualifications

• 10+ years of medical device manufacturing/process development engineering experience.
• 3+ years of engineering leadership.
• Proven Design Transfer/NPI experience taking products from development into commercial manufacturing.
• Strong knowledge of DFM/DFA, process validation, PFMEA, DOE, SPC, and process capability.
• Experience working with Contract Manufacturers.
• Strong understanding of ISO 13485, GMP, and FDA medical device requirements.
• Excellent technical leadership and cross-functional communication skills.

Responsibilities

• Build and lead a Process Development Engineering team.
• Own Design Transfer, NPI, and manufacturing readiness.
• Lead process development and IQ/OQ/PQ/PPQ validation.
• Drive DFM/DFA, process optimization, yield improvement, and cost reduction.
• Partner closely with Contract Manufacturers and suppliers.
• Establish manufacturing processes, tooling, documentation, and production readiness.
• Support sustaining engineering, engineering changes, CAPAs, and product improvements.
• Collaborate closely with R&D, Quality, Regulatory, Operations, and Manufacturing.

Skills

Engineering leadership

Cross-functional collaboration

Process development

Design transfer

Tools

DOE

PFMEA

SPC

Job description

Cambridge Recruiters seeks a Process Development Manager, R&D – Medical Devices in Redwood City, CA, to build and lead the Process Development Engineering function, driving products from development through design transfer, manufacturing validation, and commercialization.

The role requires 10+ years in medical device manufacturing/process development and 3+ years of engineering leadership, with strong ISO 13485, GMP, and FDA knowledge, plus excellent cross-functional communication.