Benefits:

401(k)

401(k) matching

Dental insurance

Health insurance

Relocation bonus

Job title : Sr. Systems Engineer Location : Pittsburg, PA

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