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Senior System Engineer
4 weeks ago
Pay Range $80000yr - $85000yr
- 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 Performance.
- (Regulatory) Compliance.
- Product Reliability.
- Technical growth/leadership.
- Stakeholder management.
- On-time delivery to commitments.
- Master s degree or equivalent in Engineering and business discipline or a like experience.
- 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.
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