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Principal / Senior Engineer (Healthcare)
RN CARE PTE. LTD.D19 Serangoon Garden, Hougang, Sengkang, Punggol, SG23 hours ago
Job descriptionBachelor’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.
Roles & Responsibilities
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
To submit your application, please apply online to apply@rn-care.com or call +65 6223 0323 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
Tell employers what skills you have
Technical Documentation
Risk Assessment
Quality Management
Technical Writing
Technology Development
Quality Management Systems
Healthcare
Business Analysis
ISO
Project Coordination
Big 4
Microsoft Word
Regulatory Requirements
Action Planning
Financial Reporting
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Principal Engineer • D19 Serangoon Garden, Hougang, Sengkang, Punggol, SG