System Engineer
3 weeks ago
Title: Sr. Systems Engineer
Location: Pittsburg, PA
Visa: Any Visa
Job Description:
Mandatory Skills:
- Systems Engineering for Electromechanical Medical Devices, InCose certification ISO 13485, ISO 14971, IEC 62304, Usability for Medical devices, Regulatory for Medical Devices Requirements Management, Jira, IEC 60601-1 and any Particular standards.
- Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance.
- Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification
- System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability.
- Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews.
- Ensuring full Product Safety Risk Management in a regulation compliant manner KPI
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