Title: Systems Engineer
Location: Remote
Duration:Â 6 months +Â
Role Summary
We are looking for a Systems Engineer to serve as the technical lead for system-level integration and traceability during DHF gap assessments. You will ensure that Design Inputs, Design Outputs, Verification & Validation, and Risk Management are complete, consistent, and fully linked across hardware, software, and subsystems for the medical device.
Responsibilities
•     Conduct comprehensive gap assessments of system requirements, architecture, and traceability matrices against Design Inputs, Design Outputs, and V&V.
•     Develop or remediate system-level specifications, interface documents, and risk analyses.
•     Support creation or updating of V&V master plans and traceability to ensure full coverage of system-level verification and validation.
•     Identify and resolve integration issues between subsystems during gap closure and remediation activities.
•     Collaborate with hardware, software, clinical, and manufacturing teams to maintain design control consistency.
Qualifications
•     Strong experience in Systems Engineering, Biomedical Engineering, or a related technical discipline.
•     Experience in medical device development, including design controls and traceability.
•     Strong working knowledge of ISO 13485, 21 CFR 820, ISO 14971, and requirements management tools.
•     Experience with risk management and V&V planning for complex electro-mechanical or software-enabled devices.
•     Excellent analytical and documentation skills; prior remediation or gap assessment experience preferred