Quality Engineer, Software Design Controls
Core
Own software design control strategy, processes, and documentation for implantable electronics, surgical robotics, and external systems to ensure compliance with medical device regulations.
Role type
Quality Engineer (Software Design Controls)
Builds
Regulated medical device software (implants, robotics, external systems)
Domain
Medical Devices / Biomedical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
software design controls, software quality, software design assurance, software development lifecycle (SDLC), requirements management, traceability matrices, risk management, verification and validation (V&V), root-cause analysis, regulatory compliance documentation
Preferred skills
implants, surgical robotics, wireless systems, Software as a Medical Device (SaMD), regulatory submissions (IDE, 510(k), PMA), cybersecurity risk assessment, usability engineering (IEC 62366), 21 CFR Part 11
Technologies
IEC 62304, ISO 14971, ISO 13485, requirements management tools
Responsibilities
Identify design control and software lifecycle risks early and drive mitigations; own software design control impact assessments for design changes; plan and execute activities supporting the full software lifecycle for Class III regulated software; debug software quality and design control gaps using traceability and anomaly data; develop and maintain software design control deliverables including design plans, requirements specifications, and traceability matrices; stay current with medical device software standards and contribute to continuous improvement of compliance processes.
Seniority
Mid-level, hands-on IC
