Senior Medical Device Development Engineer
2 weeks ago
Are you a skilled professional seeking a challenging role that combines project coordination, quality management system implementation, and risk assessment? We are looking for a talented individual to join our team as a Senior Engineer in Medical Technology.
This is an exciting opportunity to work on innovation projects aimed at adoption and commercialisation. You will assist in establishing processes and implementing risk management best practices. Your technical responsibilities will include providing guidance and development support to ongoing medical technology projects.
You will implement and maintain the office's ISO 13485 and IEC 62304-compliant quality management system processes and procedures across departmental work and projects. This includes validating unmet clinical needs, advising project teams on regulatory, quality, and risk requirements, performing risk assessments of proposed solutions with consideration of regulatory requirements, and conducting clinical need filtering and de-risking.
Your duties will also include ensuring compliance with quality, regulatory, and organisational policies while supporting required record-keeping and documentation. You will manage project tasks including recommending grants, ensuring timely completion of project milestones for successful grant applications, and meeting KPIs set by the grant agency and manager.
This role requires a combination of project coordination, quality management system implementation, risk assessment, and technical writing skills. Ideally suited for candidates with experience or strong interest in supporting medical device innovations in the healthcare industry.
Key Responsibilities:
- Establish processes and implement risk management best practices in innovation projects
- Implement and maintain ISO 13485 and IEC 62304-compliant quality management system processes and procedures
- Provide guidance and development support to ongoing medical technology projects
- Perform risk assessments of proposed solutions with consideration of regulatory requirements
- Ensure compliance with quality, regulatory, and organisational policies
- Manage project tasks related to grants: recommend grants, ensure timely completion of milestones, and meet KPIs
Qualifications:
Bachelor's or Master's Degree in Engineering or Science with minimum 2 years' experience in quality management systems, risk management processes, and/or design and development of medical devices. Experience in risk management processes for medical technology development, implementation/maintenance of a quality management system, and ISO13485 / IEC62304 audit is highly advantageous. Familiarity with ISO 13485, ISO 14971, IEC 62304, ISO14155, Medical Device Regulatory, Medical Device Standards, Risk Management for Medical Devices. Strong verbal and written communication skills with proven teamwork abilities, problem-solving skills, and technical writing skills.
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