Principal Quality Engineer (Neuromodulation/Pelvic Health)

Location: Minneapolis, Minnesota, United States; onsite 4 days per week

Salary: $120,800–$181,200 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, including neuromodulation and pelvic health therapies.

What you will do

• Lead post-market quality activities for Neuromodulation and Pelvic Health products within Service Depot operations.
• Lead complex investigations involving product quality issues, customer complaints, nonconformances, and returned product evaluations.
• Analyze post-market data, quality signals, emerging risks, and product performance trends.
• Develop and present Product Performance Reviews using quality metrics and trend analysis.
• Own complex Corrective and Preventive Actions and drive corrective actions that improve quality, compliance, and operational effectiveness.
• Lead quality improvement initiatives and collaborate cross-functionally as a quality process owner.

Requirements

• Bachelor’s degree with 7+ years of relevant experience, or an advanced degree with 5+ years of relevant experience.
• 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).
• The role is based onsite in Minneapolis, and U.S. work authorization sponsorship is available for Principal-level roles and above where applicable.

Nice to have

• Post-market quality experience in the medical device industry.
• Knowledge of FDA Quality System Regulation and ISO 13485.
• Experience with service operations, service depots, 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

• Purpose-driven work focused on improving patient outcomes.
• Health, dental, and vision insurance, plus Health Savings and Flexible Spending Accounts.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with employer contribution and match, incentive plans, and employee stock purchase plan.
• Tuition assistance, dependent daycare spending account, employee assistance, and global well-being resources.