Senior Software Quality Engineer (Medical Devices)

Location: Hybrid role based in Northridge, California, United States; other listed location: San Diego, California, United States.

Salary: $97,000–$165,000 USD annually for roles located in California.

Company

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

What you will do

• Drive software quality strategy as a quality core team member for medical mobile applications, web applications, cloud technologies, data reports, and AI/ML solutions.
• Oversee quality activities across requirements, design, development, documentation, integration, testing, verification, and validation within Agile, Waterfall, and DevOps lifecycles.
• Review and approve requirements, design documents, test results, verification and validation reports, defects, and traceability records.
• Lead system risk analysis, software FMEAs, software issue triage, and cross-functional defect management.
• Develop and maintain software quality standards, procedures, operating methods, and program criteria.
• Lead CAPA and quality improvement projects, participate in regulatory audits and QMS reviews, and support post-market FCAs or HRAs.

Requirements

• Bachelor's degree in Engineering, Science, or a technical field with 4+ years of relevant experience in Quality, Engineering, and/or Software Development, or an advanced degree in one of these fields with 2+ years of relevant experience.
• Working knowledge of medical device compliance standards including IEC 62304, ISO 13485, ISO 14971, and FDA QMSR.
• Ability to author technical reports, business correspondence, and standard operating procedures.

Nice to have

• Experience with software design, development, verification, validation, and testing for mobile applications, web applications, and cloud infrastructure services such as Amazon AWS or Microsoft Azure.
• Experience with SDLC environments, ALM tools such as PTC Integrity, Atlassian Suite, or TFS, and defect tracking tools such as Jira or PTC.
• Exposure to wireless communication protocols such as Bluetooth.
• Working knowledge of integrated digital health systems and consumer Apple or Android products.
• CQE or CSQE certification.

Culture & Benefits

• Full-time hybrid work arrangement in Northridge, California.
• Competitive compensation with a short-term incentive plan.
• Benefits for regular employees working 20 or more hours per week include health, dental, vision, HSA, FSA, life insurance, disability coverage, paid time off, and holidays.
• Additional benefits include a 401(k) with company match, Employee Stock Purchase Plan, Employee Assistance Program, and selected retirement and capital accumulation plans.
• Reasonable accommodations are available for qualified individuals with disabilities.

Hiring process

• The anticipated application window closes on 5 November 2026.