Senior Laser NPI Engineer - Medical Devices Leadership

VitalPath; Cokato (MN); On-site; USD 115,000 - 128,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

401K with company match

Paid Time Off

Holidays

Job summary

VitalPath is seeking a Senior Laser NPI Engineer to lead the transfer of laser-processed medical device components from concept to production. You will drive qualification, validation, and release-to-manufacturing while mentoring engineers and coordinating across New Product Development, Operations, Quality, and Supply Chain.

You will champion laser process standards, safety, and continuous improvement, collaborating with customers and internal teams to optimize design-for-manufacturing and cost

Qualifications

• 8+ years in catheter/medical device development/manufacturing or validation.
• 5+ years hands-on laser process development.
• Expert-level knowledge of high-tolerance laser cutting/drilling of metals and polymers.
• Experience with IQ/OQ/PQ and statistical analysis.
• Knowledge of GD&T, SolidWorks/AutoCAD, and Minitab.
• FDA regulations, ISO 13485, GMP, GDP, and QMS experience.

Responsibilities

• Serve as laser processing SME across VitalPath sites (cutting, drilling, welding, ablation, coating removal).
• Lead laser program development and hardware for complex components.
• Own releaseto-manufacturing within PhaseGate for laser NPI projects.
• Lead pilot builds and scale-up planning (throughput, yield, capacity).
• Coordinate cross-functional project execution including budgets and schedules.

Skills

Laser processing

Statistical analysis

Project management

Leadership

Customer communication

Education

Bachelor’s in Mechanical Engineering

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

GD&T

Job description

VitalPath is seeking a Senior Laser NPI Engineer to lead the transfer of laser-processed medical device components from concept to production. You will drive qualification, validation, and release-to-manufacturing while mentoring engineers and coordinating across New Product Development, Operations, Quality, and Supply Chain.

You will champion laser process standards, safety, and continuous improvement, collaborating with customers and internal teams to optimize design-for-manufacturing and cost