Sr NPI Engineer

About the role

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world. The Sr New Product Introduction Engineer leads the technical execution of qualification, validation, and transfer-to-production activities for new medical device products. This role provides engineering leadership, advanced statistical expertise, and cross-functional coordination to ensure new designs are robust, scalable, and compliant with regulatory and quality system requirements. The Senior NPI Engineer also mentors junior engineers and plays a key role in bridging New Product Development, Operations, Quality, Supply Chain, and customer engineering teams to drive successful product launches.

Responsibilities

• Lead IQ, OQ, PQ, DOE, process characterization, and capability studies.
• Develop, review, and approve validation protocols and reports.
• Lead pilot builds and ensure manufacturability and quality requirements are met.
• Apply advanced statistical tools to guide engineering decisions.
• Own and manage the release to manufacturing process within PhaseGate.
• Mentor and support junior engineers.
• Lead DFMEA, PFMEA, and control plan development.
• Oversee development of test fixtures and validation equipment.
• Lead root cause investigations and CAPA activities.
• Cookordinate cross-functional project execution.
• Lead and manage production ramp-up planning.
• Collaborate with customers on design, manufacturability, scalability, and specification reviews.
• Integrate with customers to review specifications and draft inspection criteria.
• Ensure compliance with VitalPath QMS, design controls, and FDA regulations.
• Perform additional engineering duties as required.
• Train manufacturing or other engineering team on new processes or methods.

Requirements

• Bachelor’s degree in Mechanical, Industrial, Biomedical, or related Engineering field.
• Minimum 8 years of experience in catheter or medical device development, manufacturing, or validation.
• Strong expertise in IQ/OQ/PQ and statistical analysis.
• Excellent working knowledge of GD&T, SolidWorks, and MiniTab.
• Strong understanding of medical device design and manufacturing processes.
• Demonstrated leadership and communication skills.
• Ability to work with microscopes and sit/stand for extended periods of time.
• Ability to lift up to 50 pounds.
• Travel between VitalPath sites as required.

Preferred Qualifications

• Six Sigma Green Belt or Black Belt certification.
• Experience with Lean manufacturing.
• Experience defining project budgets and schedules.
• Experience with fixture design.
• Understanding of machining principles.