Sr Eng, Codes and Standards
Core
Systems engineering and compliance professional responsible for product systems architecture, design control, and standards compliance for medical devices.
Role type
Senior Systems Engineering & Compliance Engineer
Builds
Medical device products (PSS and GSS) compliant with global regulations
Domain
Medical Devices / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems architecture, Design History File (DHF) management, Requirements management, Traceability, Risk management, System integration, Validation planning, EMC/EMI testing, Regulatory compliance strategy, Cross-functional collaboration
Preferred skills
Electromechanical systems knowledge, Fluid mechanics, Materials sciences, Wireless regulations expertise, FDA/EU MDR familiarity, Root cause analysis
Technologies
IEC/EN60601, CISPR 11, FCC, EU, IC, ETSI series, RED, FDA design control procedures
Responsibilities
Decompose system architecture into subsystem specifications; Gather requirements from standards, user needs, and regulatory bodies; Develop and execute compliance plans for global markets; Coordinate system integration and validation activities; Prepare standards test reports and submit documentation to regulatory authorities; Resolve technical issues using problem-solving tools; Ensure traceability between requirements and verification deliverables.
Seniority
Senior, hands-on IC