Sr Product Introduction Engineer

Join Vital Path in Maplewood as a Sr NPI Engineer!

Vital Path is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.

Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence.

As a fast-growing organization, we bring harmony and standardization across Vital Path with a strong vision in mind - We are one Vital Path. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that Vital Path is an employer of choice.

If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

The Senior New Product Introduction (NPI) 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.

• This position requires the employee to be onsite at our Vital Path Maplewood, MN location
• This position may require travel to our New Hope, MN location
• Vital Path does not offer relocation assistance for this position.

• 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 Phase-Gate.
• 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.
• Coordinate 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 Vital Path QMS, design controls, and FDA regulations.
• Perform additional engineering duties as required.
• Train manufacturing or other engineering team on new processes or method.
• Other engineering duties as assigned.

• 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, Solid Works, and Mini Tab
• Strong understanding of medical device design and manufacturing processes
• Experience with design controls, FDA regulations, GMP, GDP, and QMS
• 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 Vital Path sites as required

• 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…