Senior R&D Test Engineer (Medtech)

TL;DR

Senior R&D Test Engineer (Medtech): Leading the development of test methodologies and validation plans for medical devices with an accent on regulatory compliance and technical analysis. Focus on authoring complex test protocols, executing verification and validation activities, and ensuring product design meets global quality standards.

Location: Must be based in Fraser, MI, US (Hybrid: 1-2 days remote per week).

Salary: $99,680–$125,000 annually + 5% bonus target.

Company

hirify.global is a global provider of medical technology solutions for intensive care, cardiovascular procedures, and sterile reprocessing, dedicated to making life-saving technology accessible worldwide.

What you will do

• Lead Design Verification and Validation test planning, execution, and reporting.
• Develop and improve test methodologies and own Test Method Validation (TMV) for novel approaches.
• Author complex test protocols and lead failure investigations.
• Chair cross-functional reviews for protocols, reports, and deviations.
• Coach laboratory personnel and advise on verification and validation SOP improvements.
• Ensure compliance with FDA and worldwide medical device regulations.

Requirements

• Bachelor’s degree in R&D, Engineering, or a related technical discipline.
• Minimum of 5 years of experience in testing and validating new products in R&D.
• Must have the education and experience to understand and comply with U.S. and worldwide medical device regulations.
• Strong mechanical or chemical aptitude with experience in equipment troubleshooting and calibration.
• Excellent written and oral communication skills.
• Ability 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 parental/caregiver leave.
• Tuition reimbursement program.
• Wellness initiatives and health assistance resources.
• Short and long-term disability benefits.