Principal / Senior Engineer (Healthcare)

RN Care; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A healthcare technology company in Singapore is looking for a professional to ensure compliance with quality management systems and provide support for medical technology projects. The ideal candidate will hold a relevant degree and possess experience in risk management and project coordination. This role involves tracking project milestones, conducting risk assessments, and ensuring compliance with ISO standards.

Qualifications

• Experience in quality management systems and risk management processes.
• Hands-on experience in medical technology development.
• Proven track record in implementing or maintaining QMS.

Responsibilities

• Implement and maintain ISO 13485 and IEC 62304-compliant QMS processes.
• Provide technical guidance to medical technology projects.
• Conduct clinical need filtering and de-risking activities.

Skills

Quality management systems

Risk management processes

Medical device design and development

Project coordination

Education

Bachelor’s or Master’s Degree in Engineering or Science

Job description

Key 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.

To submit your application, please apply online to [e-mail] or call [phone] for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900