System engineer

1.    Review, analyze, and update product requirements to ensure completeness, consistency, and compliance with applicable quality system requirements and medical device standards.
2.    Perform requirements remediation and establish end-to-end traceability between user needs, system requirements, design inputs, risk controls, verification activities, and verification evidence.
3.    Utilize Codebeamer ALM to manage requirements, traceability links, test records, risk artifacts, and engineering documentation.
4.    Review and align verification documentation, test evidence, and verification records to ensure compliance with design control expectations.
5.    Support risk management activities by reviewing and updating FMEA documentation, hazard analyses, risk-control linkages, and risk traceability matrices.
6.    Collaborate closely with SMEs, Quality Engineering, Regulatory Affairs, Product Development, Verification, and Systems Engineering teams.
7.    Support defect review, issue resolution, and documentation updates associated with remediation.
8.    Participate in design reviews and document review sessions to ensure consistency across requirements, verification, and risk management artifacts.
9.    Perform impact assessments and support engineering change documentation where applicable.