长沙招聘

System Design Engineer


1. Position Summary:

CT System Design Engineer is responsible for the overall Systems Engineering deliverables and activities for the CT products (especially for value segment), including:

Requirement engineering, System architecture development, Risk Management, System Feature Lead, System Integration, Support Verification and Validation, Support Regulatory and Compliance, Technical Portfolio and Roadmap.

2. Key Responsibilities/Duties:

Key areas of responsibility:
· Lead product technical roadmap, and technical realization of a new platform (system level) as technical leader.
· Develop system architecture and top level design, define interfaces (Control interface, data flow, power chain, UI) and function allocation.
· Manage engineering requirements and ensure quality of requirements, refine and translate user requirements (including clinical, serviceability, reliability and manufacturability), allocate the derived requirements (including functionality, interface, performance and tolerance budgets) into subsystems.
· Explore potential technical solutions, perform feasibility study in the context of benefit/risk/ effort/cost/timeline, make technical decision, and executes system-level design reviews
· Be responsible for key system/clinical features (from concept, implementation, to integration)
· Charge of Risk Management, risk mitigation during project phases.
· Plan and Execute System Integration, aligned with cross-functional team (Clinical, HW, SW, FW)
· Owns defect analysis and remediation during System Integration, Verification and Validation phases
· Support product regulatory process (CFDA, 510k…) and safety compliance
· Care DfX, Reuse strategy, Value engineering, Target cost

3. Job Requirements:
· Master’s or PhD degree in Physics or Engineering with physics background.
· Wide technical knowledge, skills and deep understanding in at least 3 different relevant areas.
· Progressive, 8 + years of intensive experience in medical device R&D.
· Demonstrated ability in leading complex systems development “from the scratch”, where analysis requires both evaluation of multiple candidate solutions and significant evaluation of intangibles.
· Minimum 4 years of intensive experience in Systems engineering
· Proven excellence in technical leadership in a matrix environment, including demonstrated ability to influence indirect resources
· Excellent communication and conflict resolution skills
· Demonstrated ability in teambuilding, establishing common goals and working methods.
· Excellent technical writing and presentation skills to multiple levels of management. Fluency in English.
· Mindset of ‘’design control’’ and compliance in medical device industrial

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