Engineering Manager (Medical Devices)

Location: Fridley, Minnesota, United States of America. Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is offered only for Principal-level roles and above.

Salary: $142,400–$213,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies across more than 150 countries, including therapies for neurological, spinal, chronic pain, bladder, and bowel control conditions.

What you will do

• Lead, coach, and develop mechanical engineers supporting released Neuromodulation and Pelvic Health products.
• Set priorities, allocate resources, and drive execution across multiple engineering initiatives.
• Direct technical investigations, root cause analyses, CAPA activities, and product remediation.
• Partner with Quality, Regulatory, Manufacturing, Operations, Clinical, and Product Development teams to resolve product and process issues.
• Oversee design changes and product modifications through design control and change management processes.
• Drive risk mitigation, supplier investigations, qualification activities, and manufacturing issue resolution.

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 experience leading people, technical teams, or complex engineering projects.
• Experience in a regulated industry using formal design control processes.
• Experience leading technical investigations and cross-functional issue resolution.
• Experience managing multiple priorities, stakeholders, resources, and workloads.
• Engineering experience in product development, mechanical design, sustaining engineering, manufacturing engineering, or released product support.

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, handsets, or related technologies.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and long-term disability coverage.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, short-term disability, and employee assistance resources.
• Tuition assistance or reimbursement and employee stock purchase opportunities.