Senior Laser NPI Engineer - Medical Devices Leader

VitalPath; Fort Snelling Unorganized Territory (MN); On-site; USD 115,000 - 128,000; Full time

Benefits offered by this job

Health insurance

401K with company match

Paid time off

Parental leave

Vision insurance

Job summary

VitalPath in Maplewood, MN is seeking a Senior Laser NPI Engineer to lead laser processing for new medical device components from concept to production. You will own IQ/OQ/PQ, validation, and release-to-manufacturing, while mentoring engineers and coordinating cross-functional teams including Operations, Quality, and Supply Chain.

The role requires 8+ years in catheter/medical device development with 5+ years in laser process development, and hands-on expertise with high-tolerance laser systems.

Qualifications

• Minimum 8 years in catheter or medical device development, manufacturing, or validation.
• 5+ years hands-on laser process development experience.
• Expert-level knowledge of high-tolerance laser cutting/drilling of metals and polymers.

Responsibilities

• Serve as SME for laser processing across VitalPath sites.
• Lead laser program development, processes, and hardware for complex components.
• Conduct IQ/OQ/PQ, DOE, and validation protocol development and reporting.
• Own releasetomanufacturing within PhaseGate for laser NPI projects.
• Lead pilot builds, production scale-up, throughput, and capacity planning.
• Apply advanced statistical tools to guide decisions.
• Lead DFMEA, PFMEA, and control plan creation.
• Collaborate with customers on design for manufacturability and specs.
• Prepare technical responses for quotes including cost drivers and feasibility.
• Manage equipment development and qualification; establish laser standards.

Skills

Laser processing expertise

Hand-on laser development

IQ/OQ/PQ proficiency

Statistical analysis (Minitab)

GD&T knowledge

Project leadership

Customer-facing communication

Lean manufacturing awareness

Education

Bachelor’s degree in Mechanical/Manufacturing/Biomedical/related Engineering

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

Job description

VitalPath in Maplewood, MN is seeking a Senior Laser NPI Engineer to lead laser processing for new medical device components from concept to production. You will own IQ/OQ/PQ, validation, and release-to-manufacturing, while mentoring engineers and coordinating cross-functional teams including Operations, Quality, and Supply Chain.

The role requires 8+ years in catheter/medical device development with 5+ years in laser process development, and hands-on expertise with high-tolerance laser systems.