R&D Engineer II - Medical Devices | Innovate & Impact

Laborie; Maple Grove (MN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, vision

Health Savings Account with company$

401k with company match

Parental leave

Wellness programs

Job summary

Laborie is seeking an experienced R&D Engineer II to support PLM, sustaining, and new product development for consumable medical devices. You will handle design changes, material changes, and validation activities across the product life cycle, including usability and regulatory considerations.

You will collaborate with manufacturing, qualify vendors, and drive documentation in DHF, IQ/OQ/PQ, and risk management. Travel up to 25% is expected.

Qualifications

• 5+ years of R&D or Sustaining Engineer experience in medical devices.
• BS degree in biomedical, mechanical, chemical engineering or related field.
• Experience with design controls, FDA/QSR and ISO requirements.

Responsibilities

• Lead design changes and documentation to support NPD and sustaining products.
• Develop test methods, perform verification/validation, and manage DHF.
• Collaborate with manufacturing and contract vendors for equipment qualification.
• Plan IQ/OQ/PQ, risk management, and data analysis for regulatory submissions.
• Create manufacturing documents and SOPs; ensure compliance with EU MDR, ISO, FDA.

Skills

SolidWorks

CAD design

Design controls

FDA regulation

QSR requirements

Root Cause Analysis

Statistical analysis

Design for manufacturability

Vendor collaboration

Education

B.S. in Biomedical Engineering

B.S. in Mechanical Engineering

B.S. in Chemical Engineering

Tools

SolidWorks

CAD software

test fixtures

prototype fabrication

Job description

Laborie is seeking an experienced R&D Engineer II to support PLM, sustaining, and new product development for consumable medical devices. You will handle design changes, material changes, and validation activities across the product life cycle, including usability and regulatory considerations.

You will collaborate with manufacturing, qualify vendors, and drive documentation in DHF, IQ/OQ/PQ, and risk management. Travel up to 25% is expected.