Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related technical field.
3+ years of manufacturing or process engineering experience.
Experience supporting NPI, design transfer, or product commercialization.
Hands-on experience with manufacturing process development and troubleshooting.
Familiarity with process validation, including IQ/OQ/PQ.
Ability to work cross-functionally with R&D, Operations, and Quality teams.
Medical device manufacturing experience preferred.
Responsibilities
Support new product introduction from early development through manufacturing launch and production ramp-up.
Work with R&D and Engineering teams to evaluate product designs for manufacturability.
Develop, implement, and optimize manufacturing processes for new products.
Lead or support process validation activities, including IQ/OQ/PQ.
Coordinate prototype builds, pilot runs, and initial production activities.
Develop manufacturing documentation, work instructions, SOPs, and process specifications.
Troubleshoot manufacturing challenges and implement corrective actions during product launches.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to work on innovative medical device projects.
Hands-on involvement in product development and manufacturing processes.
Potential for career growth in a specialized field.
Engagement in regulatory compliance and quality assurance practices.
Full Job Description
NPI Project Manager Location: Norfolk, MA | Onsite Industry: Medical Device / Advanced Manufacturing
Position Overview We are seeking an NPI Project Manager to support the introduction and transfer of new products into manufacturing. This individual will work closely with R&D, Engineering, Operations, and Quality to develop production processes, improve manufacturability, and ensure new products are successfully transitioned into production. The ideal candidate has hands-on experience with new product introduction, manufacturing process development, and process validation in a medical device or precision manufacturing environment. Key Responsibilities
Support new product introduction from early development through manufacturing launch and production ramp-up.
Work with R&D and Engineering teams to evaluate product designs for manufacturability.
Develop, implement, and optimize manufacturing processes for new products.
Lead or support process validation activities, including IQ/OQ/PQ.
Coordinate prototype builds, pilot runs, and initial production activities.
Develop manufacturing documentation, work instructions, SOPs, and process specifications.
Troubleshoot manufacturing challenges and implement corrective actions during product launches.
Collaborate with Quality to ensure manufacturing processes meet applicable regulatory and customer requirements.
Identify opportunities to improve production efficiency, quality, and manufacturing scalability.
Support the transition of new products into sustaining manufacturing operations.
Qualifications
Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related technical field.
3+ years of manufacturing or process engineering experience.
Experience supporting NPI, design transfer, or product commercialization.
Hands-on experience with manufacturing process development and troubleshooting.
Familiarity with process validation, including IQ/OQ/PQ.
Ability to work cross-functionally with R&D, Operations, and Quality teams.
Medical device manufacturing experience preferred.
Knowledge of ISO 13485, GMP, and regulated manufacturing environments is a plus.
Experience with polymers, coatings, precision components, or specialized manufacturing processes is a plus.
