Software Design Quality Engineer (Medical Devices)

Location: Austin, Texas, United States

Base salary: $103,000–$191,000 USD annually

Company

hirify.global develops implantable brain–computer interface devices intended 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 related software.
• Partner with software and firmware teams to identify lifecycle and design control risks, define mitigations, and support design reviews.
• Assess design changes for impacts on requirements, architecture, risk controls, verification and validation, traceability, and Design History File content.
• Plan and execute software lifecycle activities for Class III and other regulated software, from requirements and architecture through implementation, verification, validation, risk management, and release.
• Develop design control plans, software requirements and architecture documents, V&V plans and reports, risk files, traceability matrices, change records, and requirement-to-test linkages.
• Investigate quality and design control gaps using requirements tools, reviews, test results, anomaly data, and root-cause analysis, while improving compliance processes and templates.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.
• 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.
• Strong understanding of SDLC practices in regulated or safety-critical environments.
• 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 interacting with the FDA or notified bodies.
• Experience with software FMEA, cybersecurity risk assessment, IEC 62366, 21 CFR Part 11, or IEC 81001-5-1.
• Experience creating design control guidelines, training programs, templates, compliance workflows, test protocols, reports, deviations, and traceability documentation.

Culture & Benefits

• Full-time employment with equity compensation through RSUs.
• Medical, dental, and vision insurance through a PPO plan.
• Paid holidays, flexible time off, parental leave, commuter benefits, and provided meals.
• 401(k) plan and opportunities for professional growth and advancement.