Product Introduction Engineer II

Overview

Join Vital Path in Maplewood as a NPI Engineer II. The New Product Introduction (NPI) Engineer II plays a key role in transforming innovative medical device concepts into scalable, production-ready solutions. This role supports qualification, validation, and transfer-to-production activities while partnering closely with R&D, Operations, Quality, Supply Chain, sustaining engineering teams. The position is hands-on, data-driven, and highly collaborative, ensuring new designs are manufacturable, robust, and compliant with regulatory and quality system requirements within the Vital Path QMS.

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 dedication is 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 other s 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 New Product Introduction (NPI) Engineer II plays a key role in transforming innovative medical device concepts into scalable, production-ready solutions. This role supports qualification, validation, and transfer-to-production activities while partnering closely with R&D, Operations, Quality, Supply Chain, sustaining engineering teams. The position is hands-on, data-driven, and highly collaborative, ensuring new designs are manufacturable, robust, and compliant with regulatory and quality system requirements within the Vital Path QMS.

• 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.

• Execute IQ, OQ, PQ, DOE, capability studies, and reliability testing.
• Develop clear, well-structured manufacturing or other work instructions, verification and validation protocols and reports.
• Support pilot builds and document results with strong attention to detail.
• Perform statistical analysis using Minitab or similar tools.
• Collaborate with R&D, Operations, Quality, Supply Chain, Sustaining Engineering team and external customer.
• Integrate with customers to review specifications and draft/review inspection criteria.
• Support development of test methods and fixture designs.
• Participate in DFMEA, PFMEA, and control plan development.
• Draft MVP documentation and monitor validation progress.
• Assist in root cause investigations and CAPA activities.
• Create and maintain engineering documentation in alignment with Vital Path QMS requirements.
• Perform other engineering duties as assigned.

• Bachelor’s degree in Mechanical, Chemical, or related Engineering field
• 2-5 years of engineering experience in NPD, manufacturing, validation, or medical device development
• Working knowledge of IQ/OQ/PQ, DOE, and statistical analysis
• Experience with catheter or medical component manufacturing preferred
• Strong communication and documentation skills
• Familiar with design controls, FDA regulations, GMP, GDP, and QMS
• Working knowledge of Solid Works, GD&T, and Minitab
• Ability to work independently with minimal supervision
• Strong organizational and documentation…