Principal Quality Engineer, Neuromodulation/Pelvic Health Minneapolis, MN (On-Site)

Location: Minneapolis, Minnesota, United States; on-site, with work performed in the workplace four days per week

Salary: $120,800–$181,200 USD annually, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies for neurological, spinal, chronic pain, and pelvic health conditions.

What you will do

• Provide post-market quality leadership and compliance oversight for Neuromodulation and Pelvic Health products in Service Depot operations.
• Lead investigations into product quality issues, customer complaints, nonconformances, and returned product evaluations.
• Analyze post-market data, quality signals, emerging risks, trends, and quality metrics.
• Develop and present Product Performance Reviews covering product performance, risks, and improvement opportunities.
• Own complex Corrective and Preventive Actions and lead corrective action implementation.
• Drive quality improvement initiatives and collaborate with cross-functional partners on quality system processes.

Requirements

• Bachelor’s degree with 7+ years of relevant experience, or an advanced degree with 5+ years of relevant experience, in quality engineering, manufacturing engineering, post-market quality, medical device quality, or a related discipline.
• Experience leading investigations involving product quality issues, customer complaints, nonconformances, or returned products.
• Experience with CAPA processes, quality system requirements, and quality risk assessment methodologies.
• Experience working in a regulated industry environment.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• U.S. work authorization sponsorship is offered for Principal-level roles and above; sponsorship may include H-1B, TN, or J visas.

Nice to have

• Post-market quality experience in the medical device industry.
• Knowledge of FDA Quality System Regulation and ISO 13485 requirements.
• Experience with service operations, Service Depot functions, manufacturing, or repair environments.
• Experience with neuromodulation or pelvic health products and therapies.
• Experience influencing cross-functional teams and mentoring engineers or technical professionals.

Culture & Benefits

• On-site collaboration focused on performance, belonging, and patient-centered healthcare innovation.
• Health, dental, and vision insurance, plus Health Savings Account and Healthcare Flexible Spending Account options for eligible regular employees.
• Life insurance, disability coverage, dependent daycare spending account, tuition assistance, and a global well-being program.
• Paid time off, paid holidays, 401(k) with employer contribution and match, employee stock purchase plan, and employee assistance program.
• Additional incentive and retirement plans may be available depending on eligibility.