New Product Introduction Engineer II

About the role

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world. The NPI Engineer II plays a key role in transforming innovative medical device concepts into scalable, production-ready solutions.

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.
• Create and maintain engineering documentation in alignment with VitalPath QMS requirements.
• Perform other engineering duties as assigned.

Requirements

• Bachelor’s degree in Mechanical, Chemical, or related Engineering field
• 25 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

Qualifications

• Required: Bachelor’s degree in Mechanical, Chemical, or related Engineering field
• Required: 25 years of engineering experience in NPD, manufacturing, validation, or medical device development
• Preferred: Six Sigma or Lean experience
• Preferred: Experience with test fixture design or process characterization
• Preferred: Understanding of design principles

Skills

• Working knowledge of IQ/OQ/PQ, DOE, and statistical analysis
• Experience with catheter or medical component manufacturing
• Strong communication and documentation skills
• Familiar with design controls, FDA regulations, GMP, GDP, and QMS
• Working knowledge of SolidWorks, GD&T, and Minitab

Benefits

• Comprehensive, low-cost health and dental insurance plans available
• Vision insurance
• Health savings account with company contribution
• Short and long-term disability supplementals (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