Process Development Manager, R&D

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

Process Development Manager, R&D – Medical Devices

Location: Redwood City, CA

We are seeking an experienced Process Development Engineering Manager to build and lead the Process Development Engineering function for an innovative, rapidly growing medical device company.

About the Company

Commercial-stage medical device company developing next-generation therapies for serious medical conditions. The company has recently commercialized its first two flagship devices in the U.S. and is now scaling its engineering and manufacturing capabilities to support continued growth and new product development.

The Opportunity

This is a high-impact leadership role serving as the critical engineering bridge between R&D, Product Development, and commercial manufacturing. You will establish the PDE function, lead a team of engineers, and drive products from development through design transfer, manufacturing validation, commercialization, and sustaining.

Key Responsibilities

• Build and lead a high-performing 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

What We're Looking For

• 10+ years of medical device manufacturing/process development engineering experience
• 3+ years of engineering leadership experience
• 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

Why This Role?

This is an opportunity to build something rather than inherit it—establishing a new engineering function at a company that has already reached a major milestone with the U.S. commercialization of its first two flagship products.

If you're a hands-on medical device engineering leader who thrives at the intersection of R&D, manufacturing, and commercialization, this is a role worth exploring.

Travel: 10-15% to US and OUS Suppliers/CM's

Local Candidates strongly preferred

Must have US Work Authorization or be a US Citizen

No H1B or C2C candidates will be considered