Principal / Senior Engineer (Healthcare)
2 weeks ago
Principal / Senior Engineer (Healthcare) 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.
- 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.
- Mid-Senior level
- Full-time
- Hospitals and Health Care
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