Sr System Engineer

Role: Sr System Engineer

Location: Pittsburg PA Onsite

Duration: Fulltime / Contract

2 POSITIONS

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 606011 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.
• Tradeoff 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
• Ontime delivery to commitments

Typically required:

• Masters degree or equivalent in Engineering and/or business discipline or alike experience