Sr Quality Engineer (New Product Development)

Location: Northridge, California, United States; hybrid workplace with on-site work required at least 3 days per week

Salary: $87,000–$149,000 USD annually

Company

hirify.global is a full-stack insulin delivery company developing intelligent dosing systems, predictive insights, and support solutions for people living with diabetes.

What you will do

• Lead system-level Design Assurance and Design Control activities for insulin pumps, CGM systems, and closed-loop or automated insulin delivery products.
• Define, trace, verify, and approve system, subsystem, and software requirements and design outputs across hardware, firmware, mobile apps, algorithms, and cloud components.
• Support system-level verification and validation plans, protocols, reports, test methods, procedures, statistical analyses, and acceptance criteria.
• Lead product risk management, including risk plans and reports, FMEAs, integrated system risk assessments, CTQ parameters, and risk controls.
• Investigate and resolve design and field defects, lead root-cause analysis and CAPA activities, and support design transfer, process validation, and inspection planning.
• Assist with internal audits, notified body audits, and regulatory inspections.

Requirements

• At least 4 years of experience in a Design Quality role within a regulated medical device environment, or an advanced degree with at least 2 years of relevant experience.
• Bachelor’s degree in engineering, science, or a related discipline.
• At least 2 years of experience leading risk management activities across the product lifecycle.

Nice to have

• ASQ Certified Quality Engineer certification.
• Experience with Software as a Medical Device or electromechanical systems, specifically IEC 62304.
• Experience in the diabetes or infusion pump industry.
• Proficiency with statistical software such as Minitab for trend analysis and data-driven assessments.
• Six Sigma Green or Black Belt certification.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971, and statistical techniques.
• Strong verbal and written communication, cross-functional facilitation, organization, prioritization, follow-up, and attention to detail.

Culture & Benefits

• Full-time employment with a flexible workplace structure and on-site collaboration in Northridge.
• Health, dental, and vision insurance; HSA and healthcare FSA access; life and disability coverage.
• Paid time off and holidays, 401(k) with company match, employee stock purchase plan, and employee assistance program.
• Short-term incentive plan and additional retirement and capital accumulation plans may be available to eligible employees.
• Benefits apply to regular employees working 20 or more hours per week; some benefits may not apply in Puerto Rico.

Hiring process

• The anticipated application window closes on 5 November 2026.