Clinical Innovation and Technology Unit (CITU) is the Research Enabler for providing clinical innovation support and implementing the SGH Research strategy masterplan (i.e. SGH Research Peaks and Enablers) to enable SGH in achieving its research vision. SGH CITU will play a central role in creating a seamless pathway to develop and/or test-bed novel technologies with application and impact to clinical outcomes or care delivery. SGH CITU aims to enable research and innovation in SGH through executing research support excellently, efficiently and with empathy.
The internal adoption framework provides a pathway for medical devices developed by SGH to be used on our patients without having to first commercialize it, thus providing direct clinical and/or operational benefits. CITU will drive internal adoption in SGH by creating and operationalizing the process to facilitate internal adoption. With the support of other offices in SGH, this process will include the review, manufacturing and post-deployment surveillance and reporting of adopted devices.
You, as a key member of RIO/CITU, will support the following:
- Establish and operationalize a framework for the adoption of selected innovations in medical devices, including software-as-medical devices, for use in SGH
- Collaborate with internal stakeholders and external manufacturing partners to facilitate the implementation of adopted devices into clinical setting
- Guide project team through productization ensuring they are ready for internal adoption within SGH while meeting patient safety, technical and regulatory requirements.
- Engage directly with clinical end users and key stakeholders to capture post-deployment insights, clinical effectiveness metrics, and cost-benefit data to evaluate innovation impact and assess commercial viability
- Create and operationalise SGH's internal adoption process covering review, manufacturing, and post-deployment phases, working closely with various offices in SGH to streamline with existing process where applicable
- Guide project teams through the Internal Adoption review and approval process, including obtaining endorsements from relevant stakeholders and buy-in from clinical department(s)
- Provide guidance to project teams on the creation of device design & development documentation according to ISO 13485 requirements
- Review device design & development documentation submitted for internal adoption. The scope of the review will include risk assessments, device safety and performance, manufacturing specifications, etc.
- Support development and maintenance of ISO 13485-aligned processes and procedures (e.g. design control and risk management protocols and software lifecycle management procedures)
- Engage project team and SingHealth Medical Technology Office to shortlist suitable contract manufacturers/vendors for device production
- Work with ALPS for the evaluation and procurement of contract manufacturer/vendor services
- Collaborate with external manufacturing partners to review manufacturing protocols and acceptance quality controls to ensure devices meet specifications and regulatory requirements
- Oversee device delivery and review acceptance testing reports of manufactured devices
- Interface with clinical end users to facilitate smooth device adoption
- Support the investigation of any device defects, adverse events, or recalls and implementation of corrective and preventive actions where relevant
- Work with project teams on continuous improvement initiatives based on clinical and cost-effectiveness data and stakeholder feedback
- Perform comprehensive risk assessments (dFMEA, SHA) per ISO 14971
- Evaluate safety and functional test data and advise project teams
- Set up and manage document control repositories with proper version control
- Provide guidance and review project teams QMS documentation
- Support adverse event investigations and implement CAPA systems
- Ensure post-market surveillance compliance
Job requirement:
- Bachelor's Degree in Engineering or Science
- Preferably with at least 2 years of relevant experience in the medical technology or healthcare industry
- Familiarity with medical device development process
- Experience in risk management processes for medical technology development
- Experience in implementation/maintenance of a quality management system
- Familiarity with ISO 13485, ISO 14971, IEC 62304, AI Medical Devices, Software-as-Medical-Device (SaMD), Medical Device Regulations, Medical Device Standards, Risk Management for Medical Device
- Experience in project coordination, technical project management, and/or technical documentation implementation/maintenance is desirable
- Meticulous, responsible and self-motivated
- Strong verbal and written communication skills with proven teamwork abilities
- Strong problem-solving skills and technical writing skills
- Strong interpersonal relationship skills.
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