Join VitalPath in Maplewood as a Sr NPI Engineer!

About VitalPath

VitalPath 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 VitalPath with a strong vision in mind - We are one VitalPath. 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 VitalPath 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!

About the Position

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.

Work Location/Schedule

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

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 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 VitalPath 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.

Required Qualifications

• 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
• 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 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

Compensation Package

• The salary range for this position is $107,250 - $143,000 . The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity.
• This position is eligible to earn an annual performance bonus based on meeting VitalPath’s bonus performance plan.

Benefits

• Comprehensive, Low Cost Health and Dental Insurance Plans Available
• Vision Insurance
• Health Savings Account with company contribution
• Short and Long Term Disability
• Supplemental insurances (short term disability, AD&D, life insurance, and more)
• Parental Leave
• Paid Time Off
• Minnesota Earned Sick & Safe Time
• Paid Holidays
• 401K with company match
• Opportunities for career growth and advancement