VitalPath · 5 hours ago
Sr New Product Introduction Engineer
St Paul, MN
Full-time
Onsite
Senior Level, Lead/Staff
$107K/yr - $143K/yr
8+ years expVitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world. The Senior New Product Introduction Engineer leads the technical execution of qualification, validation, and transfer-to-production activities for new medical device products, providing engineering leadership and cross-functional coordination for successful product launches.
Medical Device
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
Qualification
Required
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
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
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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