R&D Test Engineer (Medical Devices)

TL;DR

R&D Test Engineer (Medical Devices): Lead development of test methodologies and plans supporting verification and validation testing for medical devices with an accent on protocol development, test failure investigations, and regulatory compliance. Focus on designing novel test setups, chairing cross-functional reviews, and ensuring adherence to FDA and worldwide quality standards.

Location: Fraser, MI, US; hybrid with 1-2 days remote work

Salary: $90,000-$105,000 annually + 4% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions to improve clinical results and optimize workflows, employing over 12,000 people worldwide.

What you will do

• Translate design requirements into verification and validation testing and own test method validation for novel approaches
• Design test setups and develop complex test protocols for product testing
• Lead test failure investigations and document deviations
• Chair cross-functional reviews for protocols, test reports, and deviations
• Research test methods and standards and support improvements to SOPs and tools
• Author work instructions, protocols, and reports; perform product development and lab tasks as needed

Requirements

• Bachelor’s degree in R&D or Engineering preferred with 3-5 years experience in R&D or related field
• Must be located in or near Fraser, MI, US with hybrid work format (1-2 days remote)
• Experience with verification documentation and ability to communicate across disciplines
• Strong problem-solving, troubleshooting, data analysis, and communication skills
• Compliance with FDA and worldwide medical device regulations required
• Ability and willingness to travel to outside test labs as needed

Culture & Benefits

• Comprehensive health, dental, and vision insurance
• 401k plan with company match
• Paid time off and wellness initiatives
• Life, short and long term disability insurance
• Flexible spending accounts and commuter benefits
• Parental and caregiver leave, tuition reimbursement