Principal / Senior Engineer (Healthcare)

RN CARE PTE. LTD.; Serangoon Garden Circus; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical technology firm in Singapore is looking for a professional to implement and maintain quality management systems in compliance with ISO standards. The ideal candidate holds a Bachelor's or Master's degree in Engineering or Science and has experience in risk management processes and QMS. Responsibilities include providing technical guidance and ensuring compliance with regulatory and organizational policies.

Qualifications

• 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.

Responsibilities

• Implement and maintain ISO 13485 and IEC 62304-compliant QMS processes.
• Provide technical guidance and support to medical technology projects.
• Validate unmet clinical needs and advise on regulatory, quality, and risk requirements.

Skills

Quality management systems

Risk management processes

Technical documentation

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.

We are an equal opportunities employer and welcome applications from all qualified candidates.