Medical Device R&D Engineer – Process Validation Onsite MN

Real Staffing Group; Minnetonka (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

Real Staffing Group is seeking an R&D Engineer to join a fast-paced team supporting medical device process development. The 6-month onsite assignment in Minnetonka, MN offers potential extension or conversion for high performers.

The role focuses on authoring and executing IQ/OQ/PQ validation protocols, hands-on testing, and thorough documentation while training operators on manufacturing processes. CAD and statistical tools enhance development activities.

Qualifications

• Bachelor's degree in mechanical, biomedical, chemical engineering or related field.
• 1–3 years of experience preferred, ideally in medical device industry.
• Experience with process validations (IQ/OQ/PQ) and hands-on testing is advantageous.

Responsibilities

• Author and execute IQ/OQ/PQ validation protocols and related reports.
• Perform hands-on testing and build medical devices in lab or clean room environments.
• Document testing procedures thoroughly and train operators on manufacturing processes.
• Interact with process development, R&D, quality, manufacturing and operations teams.
• Develop and revise manufacturing documents, specifications, SOPs, safety instructions and risk assessments.

Skills

Technical Writing

Process Validation

IQ/OQ/PQ

Test Method Validation

Inspection Method Validation

Problem Solving

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Chemical Engineering

Tools

CAD

SolidWorks

Minitab

Windchill

Job description

Real Staffing Group is seeking an R&D Engineer to join a fast-paced team supporting medical device process development. The 6-month onsite assignment in Minnetonka, MN offers potential extension or conversion for high performers.

The role focuses on authoring and executing IQ/OQ/PQ validation protocols, hands-on testing, and thorough documentation while training operators on manufacturing processes. CAD and statistical tools enhance development activities.