Senior Medical Device R&D Engineer – Design & Validation

Laborie; Maple Grove (MN); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

Health Savings Account

401k with company match

Parental Leave

Wellness programs

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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%.

Skills

R&D Engineer experience

Sustaining Engineer

FDA/QSR/ISO knowledge

Root Cause Analysis

Design for Manufacturability

Cross-functional collaboration

Education

BS in Biomedical Engineering

BS in Mechanical Engineering

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

Tools

SolidWorks

CAD design software

Prototype testing fixtures

Job description

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.