Source description
About the role
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
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