Senior Quality Engineer - Post-Market Vigilance (Medical Devices)

Location: Irvine, California, United States; onsite four days per week with one remote day of choice. Candidates must have unrestricted U.S. work authorization at the time of hire and throughout employment.

Salary: $98,400–$147,600 USD per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies across more than 150 countries, with this role supporting Neurovascular products for neurological, spine, and cerebrovascular care.

What you will do

• Lead engineering evaluations of post-market complaints, product performance signals, device failure modes, use conditions, patient impact, and product risk.
• Plan and conduct complex investigations using product and process knowledge, returned-device analysis, test data, manufacturing records, and supplier information.
• Establish and document root causes, failure mechanisms, evidence limitations, and residual uncertainty.
• Partner with R&D, manufacturing, supplier quality, regulatory, clinical, marketing, and operations teams on containment, corrective actions, and product or process improvements.
• Apply design controls, risk management, statistical methods, and data analytics to identify emerging issues and evaluate changes to hazards, failure modes, and existing controls.
• Translate technical findings into recommendations for product evaluation boards, health hazard analyses, product holds, field corrective actions, and regulatory decisions.

Requirements

• 4+ years of experience with a bachelor’s degree, 2+ years with a master’s degree, or no experience requirement with a Ph.D.
• Strong statistical data analysis skills and the ability to analyze complex datasets.
• Knowledge of medical device design, materials, manufacturing processes, clinical use, and applicable FDA and international requirements and standards.
• Unrestricted U.S. work authorization is required; 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).

Culture & Benefits

• Collaborative, multidisciplinary environment focused on patient outcomes and healthcare innovation.
• Health, dental, and vision insurance, health savings and flexible spending accounts, life insurance, and disability coverage.
• Paid time off, paid holidays, employee assistance, tuition assistance, and retirement plans including 401(k) contributions and matching.
• Employee stock purchase plan and additional incentive programs for eligible regular employees.