Principal Software Quality Engineer (Digital Health)

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

Salary: $109,000–$185,000 USD annually for U.S. locations excluding Puerto Rico

Company

hirify.global develops full-stack insulin delivery systems, including intelligent dosing, predictive insights, and connected support for people living with diabetes.

What you will do

• Lead software quality as a core team member for digital health solutions across iOS/Android mobile applications, web applications, cloud technologies, data reports, and AI/ML solutions.
• Develop collaborative quality strategies with R&D, Medical Safety, Regulatory, Marketing, and DevOps teams.
• Oversee requirements, design, development, documentation, integration, testing, verification, and validation across Agile, Waterfall, and DevOps lifecycles.
• Lead design reviews, approve design artifacts, and maintain requirements traceability and process-control documentation.
• Conduct system risk analysis and software FMEAs, manage defects, and lead CAPA and quality-improvement initiatives.
• Support internal and external regulatory audits, Quality Management System reviews, and post-market FCA or HRA activities.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field plus 7+ years of relevant experience in Quality, Engineering, and/or Software Development, or an advanced degree in these fields plus 5+ years of relevant experience.
• Working knowledge of medical device compliance standards including ISO 13485, IEC 62304, HIPAA, FDA QMSR, security standards, and data privacy regulations.
• 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, or cloud infrastructure services such as Amazon AWS or Microsoft Azure.
• Experience working in SDLC environments with 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 employment in a hybrid work arrangement.
• Competitive compensation with eligibility for a short-term incentive.
• Benefits for regular employees working 20 or more hours per week include health, dental, and vision insurance, HSA and FSA access, life insurance, disability coverage, paid time off, holidays, and a 401(k) plan with company match.
• Additional programs may include an Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, and Capital Accumulation Plan.
• Reasonable accommodations are available for qualified individuals with disabilities.