Mechanical Engineering Manager - Product Release (Medical Devices)

Location: Fridley, Minnesota, United States. This is an onsite office role requiring unrestricted U.S. work authorization at the time of hire and throughout employment.

Salary: $142,400–$213,600 annually, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies for neurological, spinal, chronic pain, pelvic health, and other medical applications.

What you will do

• Lead, coach, and develop mechanical engineers supporting released Neuromodulation and Pelvic Health products.
• Set priorities, allocate resources, and manage execution across concurrent sustaining engineering initiatives.
• Direct technical investigations, root cause analyses, CAPA activities, product remediation, and risk mitigation.
• Oversee design changes and product modifications through design control and change management processes.
• Partner with Quality, Regulatory, Manufacturing, Operations, Clinical, Product Development, and suppliers to resolve product and process issues.
• Monitor team performance, workload planning, and technical capability development.

Requirements

• Bachelor’s degree with 5 years of relevant experience, or a master’s degree with 3 years of relevant experience.
• At least 2 years of people leadership experience or experience leading technical teams and complex engineering projects.
• Engineering experience in product development, mechanical design, sustaining engineering, manufacturing engineering, or released product support.
• Experience working in a regulated industry with formal design control processes.
• Experience leading technical investigations and resolving issues across multiple functions and stakeholders.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this role.

Nice to have

• Master’s degree in Mechanical Engineering.
• Medical device experience with released products or sustaining engineering organizations.
• Experience with CAPA, complaint investigations, risk management, and change control.
• Knowledge of FDA, ISO 13485, and global medical device regulations.
• Experience with implantable medical devices, neurostimulation systems, patient programmers, or handsets.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, employee assistance, and retirement plans including 401(k) contributions and matching.
• Tuition assistance, employee stock purchase plan, incentive plans, and global well-being resources.