Principal Quality Engineer (Medical Devices)

Location: Mounds View, Minnesota, United States; onsite a minimum of 4 days per week. Travel is less than 10%.

Salary: $132,000–$198,000 per year in U.S. locations excluding Puerto Rico and specific California locations.

Company

hirify.global develops medical technologies for cardiac surgery and other healthcare applications, serving patients across more than 150 countries.

What you will do

• Provide technical leadership for post-market quality activities across the commercial cardiac surgery portfolio.
• Lead health risk assessments, risk assessments, and hazard analyses using post-market data.
• Monitor field product performance, analyze reliability data, and identify trends and quality signals.
• Lead root cause investigations, failure analyses, complaint trending, and investigations of complaint trend excursions.
• Assess design and risk impacts of changes and review or approve FMEAs, test method validations, and verification and validation reports.
• Collaborate with design, manufacturing, quality, and field teams on corrective actions, product changes, customer support, and reliability improvements.

Requirements

• Bachelor’s degree in science, technology, engineering, mathematics, or a related technical discipline with at least 7 years of relevant experience; or a master’s degree with 5 years; or a PhD with 3 years.
• Experience with risk management, post-market quality, root cause investigation, failure analysis, or medical device design controls.
• For degrees earned outside the United States, the degree must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• U.S. work authorization is required for employment in the United States; sponsorship is offered for Principal-level roles and above.
• Ability to work onsite at least 4 days per week and travel less than 10%.

Nice to have

• Medical device industry experience across product development, operations, or quality.
• Expertise in risk management according to ISO 14971.
• Strong technical writing, communication, statistical data analysis, and complex problem-solving skills.

Culture & Benefits

• Purpose-driven work focused on improving patient health and product performance.
• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, disability coverage, and dependent daycare spending account.
• Tuition assistance, paid time off, paid holidays, employee assistance, and retirement benefits.
• 401(k) plan with employer contribution and match, incentive plans, and Employee Stock Purchase Plan.