About Galvanize Therapeutics Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. Backed by Norwest.
About the role
The Process Development Engineering Manager is a technical leadership role within the Research & Development organization responsible for establishing and leading the Process Development Engineering function. This role serves as the engineering bridge between Product Development and commercial manufacturing, ensuring products are designed for manufacturability, successfully transferred to contract manufacturing partners, and effectively supported throughout their commercial lifecycle.
What they're looking for
- Minimum of 10 years of experience in Manufacturing Engineering, Process Development Engineering, New Product Introduction (NPI), Sustaining Engineering, or a related medical device engineering function
- Minimum of 3 years of engineering leadership experience, including coaching, mentoring, or managing technical teams
- Demonstrated experience leading Design Transfer activities for Class III medical devices from development through commercial manufacturing
- Extensive knowledge of Design for Manufacturability (DFM), Design for Assembly (DFA), and product industrialization principles
- Demonstrated experience developing and executing manufacturing process validation strategies, including IQ, OQ, and PQ
- Strong understanding of Device Master Records (DMRs), manufacturing documentation, Design Transfer requirements, and engineering change management
More about this role
About the role
The Process Development Engineering Manager is a technical leadership role within the Research & Development organization responsible for establishing and leading the Process Development Engineering function. This role serves as the engineering bridge between Product Development and commercial manufacturing, ensuring products are designed for manufacturability, successfully transferred to contract manufacturing partners, and effectively supported throughout their commercial lifecycle.
The ideal candidate combines extensive experience in New Product Introduction (NPI), Design Transfer, manufacturing process validation, and sustaining engineering with a passion for building high-performing teams, improving engineering processes, and partnering with contract manufacturers to deliver high-quality medical devices.
Qualifications
Education and Training: Scientific degree in Mechanical, Electrical, or Biomedical Engineering with consideration given to degree level combined with experience. Other degrees within the engineering discipline are acceptable with medical device experience.
- Minimum of 10 years of experience in Manufacturing Engineering, Process Development...
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