Sr. Systems Engineer Position Available In Allegheny, Pennsylvania
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Job Description
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 Product Quality Including but not limited to: Product Performance (Regulatory) Compliance Product Reliability Technical growth/leadership Stakeholder management On-time delivery to commitments Typically Required Master’s degree or equivalent in Engineering and/or business discipline or alike experience
