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
EducationandTraining: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.
SkillsandExperience:
- 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.
- Experience working directly with contract manufacturing organizations throughout product development and commercialization.
- Working knowledge of statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Process Capability Analysis (Cp/Cpk), and Measurement System Analysis (MSA/Gage R&R).
- Experience supporting sustaining engine
What you'll do
- Establish, develop, and lead the Process Development Engineering function within the R&D organization, creating scalable processes, tools, and best practices supporting product industrialization and lifecycle management.
- Own Manufacturing Readiness Reviews, ensuring manufacturing processes, documentation, tooling, validation activities, supplier readiness, and production capability are established prior to commercialization.
- Develop Process Validation Plans, define statistical methods and acceptance criteria, and oversee execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities performed by contract manufacturing partners, ensuring validation activities meet company and regulatory expectations.
- Create, review and approve process validation protocols, reports, manufacturing documentation, Device Master Record (DMR) content, manufacturing work instructions, and related Design Transfer deliverables.
- Recruit, develop, coach, and lead a high-performing Process Development Engineering team of up to five engineers while establishing technical standards and career development plans.
- Review and approve Design Output documentation to ensure manufacturing requirements, assembly methods, inspection strategies, and process considerations are adequately defined prior to Design Transfer.
- Own engineering changes, product improvements, supplier changes, material substitutions, cost reduction initiatives, manufacturing process improvements, yield improvement projects, and obsolescence management for commercially released products.
- Support complaint investigations, CAPAs, nonconformance investigations, and other quality system activities by providing manufacturing and product engineering expertise while partnering with Product Development, Quality Assurance, and Regulatory Affairs.
- Ensure compliance with applicable regulations and standards, including 21 CFR Part 820, ISO 13485, GMP requirements, and applicable process validation guidance throughout product development and commercialization.
This role pays between $185,000 and $210,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.
Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.
Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.