Principal Software Design Engineer (Medical)
Posted Updated
Summary
Leads software design and risk management for medical projects, ensuring ISO 13485/IEC 62304 compliance and guiding teams on regulatory/quality standards.
Responsibilities:
- In charge of establishing the process and work in the team to implement risk management best practices in projects
- Implement and maintain the office's ISO 13485 and IEC 62304 compliant quality management system processes and procedures across departmental work and projects.
- Responsible in providing guidance and development support to the projects handled
- Taking charge of validating and advising project teams on regulatory, quality and risk requirements
- In charge of implementing and maintaining ISO 13485 and IEC 62304-compliant quality management system processes and procedures
- Responsible in
- In charge of managing project tasks which includes ensuring of timely completion of project milestones and meeting KPIs
- In charge of compliance with quality, regulatory and organisational policies and systems while supporting required record-keeping and documentation.
Requirements:
- Min Degree in Engineering /Science or relevant
- Min 2 years of working experience in QMS, Risk Management and design & development in medical industry
- Experience in ISO13485 /IEC62304 audit is required
To submit your application, please apply online to apply@rn-care.com or call +(65) 6513 5697 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