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 complex protocol execution. Focus on design verification, test method validation, and ensuring product quality in alignment with global medical device 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 innovative medical technology solutions for intensive care, cardiovascular procedures, and sterile reprocessing, dedicated to making life-saving care accessible worldwide.

What you will do

• Lead Design Verification and Validation test planning, execution, and reporting.
• Develop and own Test Method Validation (TMV) for novel testing approaches.
• Author complex R&D protocols and manage test failure investigations.
• Chair cross-functional reviews for protocols, reports, and deviations.
• Coach laboratory personnel and advise on SOP improvements.
• Ensure all testing activities comply 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.
• Must be authorized to work in the U.S. and comply with U.S. medical device regulations.
• Strong mechanical or chemical aptitude with experience in troubleshooting and calibrating lab equipment.
• Excellent written and oral communication skills for technical and cross-functional collaboration.
• Ability to travel to outside test labs for offsite testing activities.

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.