Novozen Healthcare LLCRemote
System Engineer
United States of America
Contract
2 days ago
H1B Sponsor Likely
Key skills
Systems EngineeringMedical DevicesISO 1348521 CFR Part 820ISO 14971Design ControlsRequirements ManagementRisk ManagementVerification and Validation (V&V) PlanningDesign History File (DHF) RemediationTraceabilityCollaboration
About this role
Novozen Healthcare LLC is seeking an experienced Systems Engineer to support medical device design remediation and system integration activities. The ideal candidate will have strong expertise in Systems Engineering, Design Controls, Traceability, Risk Management, and V&V for complex medical devices.
Responsibilities:
- Conduct system-level gap assessments and traceability reviews
- Develop and remediate system specifications, interface documents, and risk analyses
- Support V&V planning and maintain complete Design Input/Output traceability
- Resolve subsystem integration issues during remediation activities
- Collaborate with hardware, software, manufacturing, and clinical teams to ensure design control compliance
Requirements:
- 10–15 years of Systems Engineering experience in medical devices
- Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, Design Controls, and Requirements Management
- Experience with risk management, V&V planning, DHF remediation, and traceability
- Excellent analytical, documentation, and cross-functional collaboration skills