Sr SW Design Quality Engineer
Core
Ensures conformance to software development processes and safety/quality regulations (IEC 62304, ISO 13485, ISO 14971) for continuous glucose monitoring devices.
Role type
Senior Software Design Quality Engineer
Builds
Medical device software ensuring regulatory compliance and defect prevention
Domain
Medical device / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IEC 62304 compliance, 21 CFR 820 knowledge, ISO 13485 experience, SDLC process expertise, risk management (FMEA, SHA), software design review, change control assessment, technical documentation authoring
Preferred skills
ASQ CSQE certification, Cybersecurity experience, Cloud infrastructure experience
Technologies
IEC 62304, ISO 13485, ISO 14971, 21 CFR 820, Agile, Waterfall
Responsibilities
Lead pre-market risk management deliverables including SHA and design FMEA, review and approve software design control deliverables, support post-market anomaly assessments and CAPA activities, assess impact of change control on product compliance, author and revise technical documentation including design history files and SOPs, provide guidance to software design and test teams on configuration management and tool validations
Seniority
Senior, hands-on IC