Principal / Senior Engineer, Innovation (Quality & Risk Management Systems), MTO

Join SingHealth's Medical Technology Office (MTO) and play a pivotal role in advancing medical device innovation across Singapore's largest public healthcare cluster. You will be part of a dynamic team that bridges clinical needs with cutting-edge technology solutions, ensuring that innovative medical devices meet the highest quality and safety standards whilst supporting our mission to transform healthcare through innovation.

We are seeking a Principal / Senior Engineer to lead quality management system implementation and risk management processes for investigational medical device studies, adoption, and commercialisation projects. You will work closely with clinicians, technology partners, and project teams to establish robust ISO13485 and IEC62304-compliant processes whilst providing technical guidance for our ongoing MedTech development initiatives.

What You Will Do:

You will lead comprehensive risk assessments for medical device and Software as Medical Device innovation projects, ensuring regulatory compliance through robust quality management systems. Your responsibilities include creating risk management reports, conducting clinical need validation and de-risking activities, and maintaining detailed audit documentation.

You will provide regulatory and quality management guidance to project teams whilst managing milestones and supporting grant applications. Additionally, you'll support MTO's educational initiatives with Duke-NUS and SingHealth, including seminars, outreach events, and project attachments for clinician innovators. Administrative duties include procurement assistance and organised documentation of meetings and communications.

This role combines project coordination, quality management system implementation, risk assessment and technical writing. It is ideally suited for candidates with experience or strong interest in supporting medical device innovations in the healthcare industry.  

Job Requirements:

• Bachelor's or Master's Degree in Engineering or Science with minimum 2 years of experience in medical device quality management systems and risk management processes
• Experience creating Design History Files and implementing quality management systems
• Strong technical writing, problem-solving, and communication abilities
• Familiarity with ISO 13485, ISO 14971, IEC 62304, and medical device regulatory standards
• Project coordination experience preferred; ISO13485/IEC62304 audit experience and software development lifecycle knowledge highly advantageous
• Passion for medical technology innovation, with meticulous attention to detail