Principal / Senior Engineer (Healthcare)

RN CARE PTE. LTD.; Serangoon Garden Circus; On-site; SGD 60,000 - 90,000; Full time

Job summary

A medical technology company based in Singapore is seeking an individual to implement and maintain ISO-compliant QMS processes. The role involves providing technical guidance, conducting risk assessments, and managing project-related tasks. Ideal candidates will have a degree in Engineering or Science and experience in quality management systems. Competitive compensation and support for professional development are offered.

Qualifications

• Experience with ISO 13485 / IEC 62304 audits is highly advantageous.
• Healthcare experience is highly advantageous.
• Hands-on experience in risk management for medical technology.

Responsibilities

• Implement and maintain ISO 13485 and IEC 62304-compliant QMS processes.
• Coordinate and manage project-related tasks effectively.
• Track and ensure timely completion of project milestones.

Skills

Quality management systems

Risk management processes

Medical technology development

Project coordination

Technical documentation

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