Senior Design Quality Engineer (Neurovascular)

Location: Irvine, California, United States; onsite work four days per week

Salary: $107,200–$160,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life. The Neurovascular business develops technologies for precise treatment of stroke and cerebrovascular disease.

What you will do

• Partner with R&D and Process Development teams to influence product design throughout the development lifecycle.
• Lead reliability studies, design characterization activities, and design of experiments to evaluate product and process performance.
• Apply risk management methods to identify, assess, and mitigate product and process risks through commercialization.
• Develop test methods, statistical approaches, and process controls that support reliability and quality objectives.
• Analyze product, process, and investigation data to identify improvements and support engineering decisions.
• Provide quality leadership for verification, validation, design transfer, and cross-functional project execution while mentoring engineers.

Requirements

• Bachelor’s degree in Engineering or Science with at least 4 years of engineering or quality experience, or an advanced degree with at least 2 years of relevant experience.
• Experience in product development, design quality, quality engineering, or related engineering work.
• Experience applying statistical analysis and data-driven problem-solving to engineering or quality challenges.
• Experience working in a regulated environment with design controls, risk management, verification, or validation.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.
• Degrees earned outside the United States must meet the stated U.S. H-1B educational-equivalence requirements.

Nice to have

• Experience with vascular or neurovascular medical devices.
• Advanced statistical analysis using Minitab, Design of Experiments, capability analysis, stability analysis, and graphical analysis.
• Knowledge of ISO 13485, EU MDR, and FDA Quality System Regulation.
• Experience with requirements flow-down, design characterization, or metals and polymer material engineering and testing.

Culture & Benefits

• Collaborative onsite environment focused on performance, belonging, and cross-functional innovation.
• Health, dental, and vision insurance, plus HSA and healthcare FSA options.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance, life insurance, disability coverage, employee stock purchase plan, and employee assistance program.
• Short-term incentive eligibility through the hirify.global Incentive Plan.