Senior Medical Device R&D Engineer – Design & Validation

Laborie; Maple Grove (MN); Vor Ort; USD 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Paid time off

Medical, Dental, Vision

Health Savings Account

401k with company match

Parental Leave

Wellness programs

Zusammenfassung

Laborie in Minnesota is seeking a Senior R&D Engineer to drive product design, development, and manufacturing for advanced medical devices. You will lead cross-functional teams, develop verification/validation plans, and ensure compliance with FDA/QSR and ISO standards.

Join a mission-driven company with strong focus on patient outcomes. Expect growth opportunities, collaboration across departments, and travel up to 25% as needed.

Qualifikationen

• 8+ years' experience as a R&D or Sustaining Engineer in regulated medical devices (FDA/QSR/ISO).
• BS degree in Biomedical, Mechanical, Chemical Engineering or related field with 7+ years' FDA/QSR/ISO experience.
• Strong knowledge of injection molding, device design and manufacturability for catheters and related processes.

Aufgaben

• Lead new product development and product/process improvements for consumable medical devices.
• Collaborate with cross-functional partners on sustaining engineering.
• Develop product test methods and conduct V&V, IQ/OQ/PQ and risk management.
• Prepare and approve manufacturing documents and ensure compliance with EU MDR, ISO, FDA.
• Travel up to 25%.

Kenntnisse

R&D Engineer experience

Sustaining Engineer

FDA/QSR/ISO knowledge

Root Cause Analysis

Design for Manufacturability

Cross-functional collaboration

Ausbildung

BS in Biomedical Engineering

BS in Mechanical Engineering

Master's/PhD in Biomedical/Mechanical/Chemical Eng

Tools

SolidWorks

CAD design software

Prototype testing fixtures

Jobbeschreibung

Laborie in Minnesota is seeking a Senior R&D Engineer to drive product design, development, and manufacturing for advanced medical devices. You will lead cross-functional teams, develop verification/validation plans, and ensure compliance with FDA/QSR and ISO standards.

Join a mission-driven company with strong focus on patient outcomes. Expect growth opportunities, collaboration across departments, and travel up to 25% as needed.