Description

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

Key Skills
Education

Master’s degree

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