Quality Engineer, Software Design Controls (Medical Devices)

Location: Austin, Texas, United States

Salary: $103,000–$191,000 USD base salary per year, plus equity compensation for full-time employees.

Company

hirify.global develops brain-computer interface devices designed to restore movement and sight and transform interaction with digital systems.

What you will do

• Own software design control strategy, processes, documentation, and continuous improvement across implantable electronics, surgical robotics, external systems, and supporting software.
• Partner with software and firmware teams to identify lifecycle and design control risks, drive mitigations, and support design reviews using IEC 62304 practices.
• Assess the impact of design changes on requirements, architecture, risk controls, verification, validation, and traceability.
• Plan and execute software lifecycle activities for Class III and other regulated software, from requirements and architecture through release.
• Develop and maintain design control deliverables, including requirements specifications, architecture documents, V&V plans and reports, risk files, traceability matrices, and change records.
• Investigate quality and design control gaps using code and architecture reviews, test results, anomaly data, requirements tools, and root-cause analysis.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline.
• 3+ years of hands-on experience in software design controls, software quality, or software design assurance for medical devices.
• Strong understanding of the SDLC in regulated or safety-critical environments and practical experience applying design controls.
• Experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
• Working knowledge of IEC 62304, ISO 14971, and ISO 13485.
• Strong cross-functional communication skills and the ability to drive issues to closure across engineering, quality, regulatory, and external partners.

Nice to have

• Experience with implants, surgical robotics, wireless systems, SaMD, or SiMD.
• Experience contributing software design control or V&V data to IDE, 510(k), PMA, or equivalent regulatory submissions and working with the FDA or notified bodies.
• Experience with software FMEA, cybersecurity risk assessment, medical device design controls, and regulated product development.
• Experience creating design control guidelines, training programs, templates, or compliance workflows.
• Familiarity with IEC 62366, 21 CFR Part 11, IEC 81001-5-1, and regulated test documentation.

Culture & Benefits

• Opportunity to work on brain-computer interface technologies with multidisciplinary experts.
• Growth opportunities based on impact.
• Medical, dental, and vision insurance through a PPO plan.
• Paid holidays, flexible time off, commuter benefits, and provided meals.
• Equity compensation through RSUs and a 401(k) plan.
• Parental leave for eligible full-time employees.