R&D Engineer II - Medical Devices, Design & Validation

Laborie; Salt Lake City (UT); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

Job summary

Laborie, a world-class medical device company in Utah, seeks an experienced R&D Engineer II to support new product development and sustaining efforts for consumable devices. You will handle design changes, verification/validation, and manufacturability partnerships to meet revenue, quality, and cost goals.

You will work with cross-functional teams to implement design controls, risk management, and regulatory compliance while traveling up to 25% as needed.

Qualifications

• BS degree in Biomedical, Mechanical, Chemical Engineering or related.
• 5+ years in R&D or Sustaining Eng. in medical devices with FDA/QSR/ISO exposure.
• Experience with injection molding and assembled consumables.
• SolidWorks CAD and test fixture design experience.
• Knowledge of design controls, FDA/GMP and QSR requirements.
• End-to-end product development lifecycle experience.
• Root cause analysis and corrective actions process experience.

Responsibilities

• Develop new product development and process improvement for consumables.
• Design, prototyping, material selection, verification/validation for devices.
• Collaborate with manufacturing to qualify equipment vendors.
• Plan, document, and execute design verification/validation; risk mgmt.
• Prepare processes, protocols, reports and other controlled docs.
• Ensure compliance with EU MDR, ISO, FDA, and related regs.
• Support full lifecycle of product development including usability studies.
• Travel up to 25%.

Skills

R&D engineering

Sustaining engineering

Medical devices

SolidWorks

Design controls

FDA/QSR/ISO compliance

Root cause analysis

Product development lifecycle

Education

BS degree in Biomedical, Mechanical, Chemical Engineering or related

Tools

CAD software

Minitab

Prototyping equipment

Documentation tools

Job description

Laborie, a world-class medical device company in Utah, seeks an experienced R&D Engineer II to support new product development and sustaining efforts for consumable devices. You will handle design changes, verification/validation, and manufacturability partnerships to meet revenue, quality, and cost goals.

You will work with cross-functional teams to implement design controls, risk management, and regulatory compliance while traveling up to 25% as needed.