Principal / Senior Engineer (Healthcare)

4 days ago

Singapore RN Care Pte. Ltd. Full time

Principal / Senior Engineer (Healthcare) Responsibilities

  • Implement and maintain ISO 13485 and IEC 62304-compliant QMS processes across projects and departmental work.
  • Provide technical guidance and development support to medical technology projects.
  • Validate unmet clinical needs and advise project teams on regulatory, quality, and risk requirements.
  • Perform risk assessments of proposed solutions with consideration of regulatory requirements.
  • Conduct clinical need filtering and de-risking activities.
  • Ensure compliance with quality, regulatory, and organisational policies, including documentation and record-keeping.
  • Coordinate and manage project-related tasks, including recommending and supporting grant applications.
  • Track and ensure timely completion of project milestones and deliverables.
  • Meet KPIs set by grant agencies and management.
  • Contribute to project coordination, risk assessment, quality management implementation, and technical writing.
Job Requirements
  • Bachelor’s or Master’s Degree in Engineering or Science.
  • Experience in quality management systems, risk management processes, and/or medical device design and development.
  • Hands-on experience in risk management processes for medical technology development.
  • Proven track record in implementing or maintaining QMS.
  • Experience with ISO 13485 / IEC 62304 audits is highly advantageous.
  • Healthcare experience is highly advantageous.
  • Experience in project coordination, technical project management, and/or technical documentation is desirable.
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Industries
  • Hospitals and Health Care
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