Senior Supplier Quality Engineer (Medical Devices)

Location: Brooklyn Park, Minnesota, United States of America; onsite at least 4 days per week. Travel is less than 10%.

Salary: $99,200–$148,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Execute supplier quality activities throughout the new product development lifecycle for cardiac surgery devices.
• Lead supplier and component qualification, including process development reviews, capability assessments, readiness evaluations, and PPAP approval.
• Assess supplier changes and their impact on qualifications, validations, product risks, and commercialization timelines.
• Plan and lead supplier audits, monitor supplier performance, and ensure compliance with regulatory standards and internal procedures.
• Resolve supplier issues through structured problem-solving and timely corrective and preventive actions.
• Partner with R&D, Manufacturing Engineering, Regulatory, and Sourcing teams on manufacturability, quality, inspection, and test method validation.

Requirements

• Bachelor’s degree and 4+ years of relevant experience, or a master’s degree with 2+ years of relevant experience, or a PhD with no prior experience required.
• Experience managing supplier and component qualification during new product development programs.
• Knowledge of PPAP, supplier qualification documentation, process validation, and supplier readiness activities.
• Ability to coordinate supplier quality deliverables across cross-functional teams and project timelines.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Engineering experience in the medical device industry, particularly disposable devices or capital equipment.
• Understanding of cardiovascular device applications and general heart anatomy.
• Experience supporting cross-functional and cross-regional teams in a matrixed organization.

Culture & Benefits

• In-person collaboration and cross-functional professional development are emphasized.
• Health, dental, and vision insurance, health savings and flexible spending accounts, and life insurance.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and short-term disability coverage.
• Tuition assistance, employee stock purchase plan, employee assistance program, and incentive plans.