VitalPath · 8 hours ago
New Product Introduction Engineer II
St Paul, MN
Full-time
Onsite
Entry, Mid Level
$68K/yr - $91K/yr
2+ years expVitalPath is a trusted contract manufacturing partner delivering high-quality complex catheter solutions. The New Product Introduction Engineer II will transform innovative medical device concepts into scalable, production-ready solutions while collaborating with various teams to ensure compliance with regulatory and quality system requirements.
Medical Device
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
Qualification
Required
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
Preferred
Six Sigma or Lean experience
Experience with test fixture design or process characterization
Understanding of design principles
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
Company
VitalPath
VitalPath is a medical & catheter and medical design company.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Nicole Ramus
Vice President, Global Sales
Recent News
BioWorld Financial Watch
2025-03-05
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