Process Development Engineering Lead – Medical Devices

Galvanize; Redwood City (CA); Sur place; USD 185 000 - 210 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

Life Insurance

Short- and Long-term Disability

401(k)

Flexible Paid Time Off

Résumé du poste

Galvanize Therapeutics in Redwood City, CA, seeks a Process Development Engineering Manager to lead the Process Development Engineering function within R&D, bridging Product Development and contract manufacturing to ensure manufacturability and lifecycle support.

The ideal candidate brings extensive NPI, Design Transfer, and process validation experience for Class III medical devices, and a track record of building high-performing teams while partnering with CMOs and Quality/Regulatory groups.

Qualifications

• Scientific degree in Mechanical, Electrical, or Biomedical Engineering with consideration given to degree level combined with experience.
• Minimum of 10 years in Manufacturing Engineering, Process Development/ NPI / Sustaining Engineering in medical devices.

Responsabilités

• Establish, develop, and lead the Process Development Engineering function within R&D, creating scalable processes and best practices.
• Own Manufacturing Readiness Reviews, ensuring processes, documentation, tooling, validation activities, supplier readiness, and production capability before commercialization.
• Develop Process Validation Plans and oversee IQ, OQ, PQ activities with contract manufacturers, ensuring regulatory expectations are met.
• Create, review, and approve DMR content, process validation protocols, reports, and related Design Transfer deliverables.
• Recruit, develop, coach, and lead a team of up to five engineers, setting technical standards and career development paths.
• Review and approve Design Output documentation to ensure manufacturing requirements are defined prior to Design Transfer.
• Own engineering changes, product improvements, supplier changes, cost reductions, and obsolescence management for released products.
• Support CAPAs, nonconformances, and quality system activities with manufacturing and product engineering expertise.

Connaissances

NPI & Design Transfer

Engineering Leadership

DFM / DFA / Industrialization

Process Validation IQ/OQ/PQ

DOE / SPC / CpCpK / MSA

Regulatory & Quality Systems

Contract Manufacturers Collaboration

Formation

Scientific degree in Mechanical, Electrical, or Biomedical Engineering

Description du poste

Galvanize Therapeutics in Redwood City, CA, seeks a Process Development Engineering Manager to lead the Process Development Engineering function within R&D, bridging Product Development and contract manufacturing to ensure manufacturability and lifecycle support.

The ideal candidate brings extensive NPI, Design Transfer, and process validation experience for Class III medical devices, and a track record of building high-performing teams while partnering with CMOs and Quality/Regulatory groups.