Sr. Software Systems Engineer
Core
Ensure software and system-level design activities are planned, executed, and documented in compliance with quality and regulatory requirements for software-intensive medical device systems.
Role type
Senior Software Systems Engineer (Design Quality)
Builds
Software-enabled medical devices for neuromodulation and pelvic health
Domain
Medical device / Healthcare technology / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems engineering, Software development lifecycle, Design controls, Risk management, Verification and validation, Regulatory compliance, Requirements traceability, Cross-functional collaboration
Preferred skills
Medical device industry experience, IEC 62304/ISO 14971/ISO 13485 knowledge, Agile development, AI in process development, Software architecture reviews, Cybersecurity, Usability/human factors
Technologies
None explicitly listed
Responsibilities
Provide design quality support from concept through transfer to manufacturing, Review and contribute to system/software requirements and architecture, Support development of verification and validation strategies, Partner with cross-functional teams to resolve design quality issues, Evaluate software development deliverables for regulatory readiness, Participate in design reviews and root cause analysis, Mentor less experienced engineers on design quality practices
Seniority
Senior, hands-on IC with mentorship responsibilities