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.