New Product Introduction Engineer II

VitalPath•Saint Paul, MN

9h•$68,475 - $91,300•Onsite

About The Position

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 VitalPath QMS.

Requirements

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 SolidWorks, GD&T, and Minitab
Ability to work independently with minimal supervision
Strong organizational and documentation abilities
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

Nice To Haves

Six Sigma or Lean experience
Experience with test fixture design or process characterization
Understanding of design principles

Responsibilities

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 VitalPath QMS requirements.
Perform other engineering duties as assigned.