Software Design Quality Engineer

Responsibilities

• Own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software.
• Partner with software and firmware teams to identify design control and software lifecycle risks, drive mitigations, and support design reviews using IEC 62304 practices.
• Lead design control impact assessments for changes and evaluate effects on requirements, architecture, risk controls, verification and validation, and traceability.
• Plan and execute software lifecycle activities for Class III and other regulated software, including requirements, architecture, design, implementation, verification, validation, risk management, and release.
• Debug software quality and design control gaps using requirements management tools, traceability matrices, code and architecture reviews, test results, anomaly data, and root-cause analysis.
• Develop and maintain design and development plans, software requirements specifications, architecture documents, verification and validation plans and reports, risk files, traceability matrices, change records, and requirement-to-test linkages.
• Maintain risk assessments, protocols, and Design History File content to support ongoing compliance.
• Contribute to improvements in compliance processes, standard operating procedures, templates, and cross-functional knowledge sharing.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline.
• At least 3 years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.
• Strong understanding of the software development lifecycle in regulated or safety-critical environments and practical application of design controls.
• Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
• Working knowledge of IEC 62304, ISO 14971, and ISO 13485.
• Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device or Software in a Medical Device is preferred.
• Experience contributing software design control or verification and validation data to regulatory submissions and interfacing with the FDA or notified bodies is preferred.
• Experience with medical device design controls, ISO 14971 risk management including software FMEA or SFMEA, cybersecurity risk assessment, and regulated product development lifecycles is preferred.
• Experience developing software design control guidelines, training programs, templates, or compliance workflows is preferred.
• Familiarity with IEC 62366, 21 CFR Part 11, or cybersecurity guidance including FDA guidance and IEC 81001-5-1 is preferred.
• Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in regulated or quality-controlled development processes is preferred.

Benefits

• Full-time employees receive medical, dental, and vision insurance through a PPO plan.
• Paid holidays, commuter benefits, meals, equity in the form of RSUs, a 401(k) plan, parental leave, and flexible time off are offered; some benefits exclude temporary employees and interns.
• The role is full-time.