Senior Systems Engineer
Core
Lead Quality Management System (QMS) development, sustain engineering, and ensure regulatory compliance for in vitro diagnostic products.
Role type
Senior Systems Engineer (Sustaining Engineering & Compliance)
Builds
Sustaining engineering activities and compliant diagnostic product lifecycles
Domain
Medical diagnostics / In vitro diagnostics / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), Design Controls, product lifecycle management, sustaining engineering, regulatory compliance, technical leadership, cross-functional collaboration, process improvement, design reviews
Preferred skills
FDA/ISO 13485 regulated environment experience, advanced degree in Engineering or Life Sciences
Technologies
QMS tools, Design Control tools
Responsibilities
Lead QMS process development and improvement, maintain technical documentation, provide training on quality processes, lead sustaining engineering activities, drive process improvement initiatives, lead design reviews
Seniority
Senior, hands-on IC with technical leadership
