Senior Clinical Innovation Engineer - Singapore - SingHealth Group

SingHealth Group

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

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Description

Singapore Health Services Pte Ltd
Senior Clinical Innovation Engineer (Risk Management), Medical Technology Office:

Job Category: Administration

Posting Date: 1 Feb 2024You will assist to establish processes and work in a team to implement risk management best practices in innovation projects aimed at adoption and commercialisation.

You will be involved in the implementation and maintenance of the office's ISO13485-compliant quality management system processes and procedures in the department's work and projects.

You will provide technical guidance and development support to the office's ongoing medical technology development projects which include but are not limited to supporting validation of unmet clinical needs in projects, providing inputs to project teams on regulatory, quality and risk requirements, performing basic risk assessment of proposed solutions with consideration to regulatory requirements and conducting clinical need filtering and de-risking.

Job Requirements

PhD in Engineering or Science with relevant experience in quality management systems and/or risk management processes
Master's Degree in Engineering or Science with minimum 2 years of experience in quality management systems and/or risk management processes
Bachelor's Degree in Engineering or Science with minimum 4 years' experience in quality management systems and/or risk management processes
Experience in risk management processes for medical technology development
Experience in implementation/maintenance of a quality management system
Experience in QMS audit will be a strong advantage
Familiarity with ISO 13485, ISO 14971, IEC 62304, ISO14155, Medical Device Regulatory, Medical Device Standards, Risk Management for Medical Devices
Good problemsolving skills with strong technical writing focus
Excellent communication and technical writing skills
Meticulous, responsible, selfmotivated and a good communicator
Must be fully vaccinated against COVID19
Req ID: 3095