What are the responsibilities and job description for the Senior Process Engineer – Medical Device Manufacturing position at NorthPole Group Inc?
Senior Process Engineer – Medical Device Manufacturing
Location: Marlborough, MA (Onsite)
We're looking for an experienced Process Engineer III to join a leading medical device organization. This role is ideal for engineers with a strong background in manufacturing process engineering, technology transfer, process validation, and continuous improvement within a GMP/ISO 9001 regulated environment.
Key Responsibilities
- Lead technology transfer and manufacturing process support activities
- Drive process development, optimization, and continuous improvement initiatives
- Execute process validation and equipment qualification (IQ/OQ/PQ)
- Support new product introductions (NPI) into manufacturing
- Troubleshoot manufacturing issues and implement CAPA solutions
- Collaborate with Quality, Manufacturing, R&D, and Engineering teams
- Ensure compliance with GMP, ISO 9001, and regulatory requirements