System Engineer

Mandatory Skills: Systems Engineering for Electromechanical Medical Devices 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