Staff Design Quality Assurance Engineer (Medical Devices)

Location: Hybrid; on-site work required at an hirify.global office in San Diego, California, United States

Annual base salary: $117,700–$176,500 for U.S.-based positions; incentive compensation may also apply.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other subcutaneous drug-delivery solutions.

What you will do

• Lead design control and quality engineering activities for FDA Class II and III medical devices across system, hardware, and software development.
• Ensure complete Design History File documentation and compliance with FDA, ISO, and IEC requirements.
• Integrate system-level risk management, requirements, risk controls, traceability, verification, and validation.
• Review requirements, specifications, design documentation, risk files, validation protocols, test plans, and reports.
• Partner with R&D, systems, hardware and software engineering, cybersecurity, manufacturing, human factors, regulatory affairs, and project management.
• Establish quality processes, metrics, governance, and training while leading data-driven continuous improvement initiatives.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related field; a master’s degree is preferred.
• At least 8 years of medical device industry experience with strong knowledge of design controls and quality systems.
• Deep understanding of FDA QSR, FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62304, and related standards.
• Experience implementing SDLC best practices in regulated environments and leading cross-functional improvement projects.
• Strong communication, leadership, program management, stakeholder management, analytical, and problem-solving skills.
• Ability to work in a hybrid arrangement with required on-site attendance at the San Diego office.

Nice to have

• Lean Six Sigma Green Belt certification or higher.
• Master’s degree in engineering, life sciences, or a related field.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Performance-driven environment focused on customer expectations and shared values.