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

Company Overview / Employee Value Proposition

VISION MANPOWER PTE LTD is a Singapore-based manpower agency specializing in professional staffing solutions across various industries.

Job Summary

Join 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.

• Lead comprehensive risk assessments for medical device and Software as Medical Device innovation projects to ensure regulatory compliance and patient safety
• Develop and maintain risk management reports aligned with ISO 14971 standards to support project decision-making
• Conduct clinical need validation and de-risking activities to align technology solutions with healthcare requirements
• Implement and manage quality management systems compliant with ISO 13485 and IEC 62304 for investigational device studies and commercialization projects
• Provide regulatory and quality management guidance to multidisciplinary project teams to facilitate successful project milestones and grant applications
• Maintain detailed audit documentation and Design History Files to support regulatory inspections and internal reviews
• Coordinate project activities including procurement assistance, meeting documentation, and communication management to ensure smooth project execution
• Support educational initiatives such as seminars, outreach events, and project attachments to foster clinician innovation and knowledge sharing
• Apply strong technical writing skills to produce clear, accurate, and compliant documentation for regulatory and project purposes
• Collaborate effectively with clinicians, technology partners, and stakeholders to drive medical technology development and adoption

• Experience in project coordination within medical device development environments
• Knowledge of software development lifecycle processes relevant to medical device software
• ISO 13485 and IEC 62304 audit experience
• Passion for medical technology innovation with meticulous attention to detail

• Work Hours: Monday – Friday (Office Hours)
• Salary will be commensurate with experience.

EA License No: Vision Manpower Pte Ltd (02C5351)