Principal / Senior Engineer, Innovation (Quality, Risk Management & Software), MTO

We are seeking an innovation Engineer maintain and implement quality management systems of medical technology innovation projects with a large focus in Software-as-Medical-Device (SAMD). You will also be required to support risk assessment of medical devices.

You will assist to establish processes and work in a team to implement risk management best practices in innovation projects aimed at adoption and commercialisation. 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.

Your technical responsibilities include providing guidance and development support to ongoing medical technology projects which will mainly consist of  Software as Medical Device (SaMD). This encompasses 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.

You will ensure compliance with quality, regulatory and organisational policies and systems while supporting required record-keeping and documentation. Managing project tasks includes recommending grants, ensuring timely completion of project milestones for successful grant applications, and meeting KPIs set by the grant agency and manager.

This role combines project coordination, quality management system implementation, risk assessment and technical writing. It is ideally suited for candidates with experience or strong interest in supporting medical device innovations in the healthcare industry.

Job Requirements

• Bachelor’s or Master’s Degree in Engineering, Science or Computer Science with minimum 2 years’ experience in enterprise IT design, development and deployment, quality management systems, risk management processes, or design and development of medical devices

• Familiarity with popular frameworks (for the purpose of quality management system) will be required, such as NodeJS; mobile app frameworks e.g. React; mobile platforms e.g. IOS, Android; popular cloud platforms e.g. GCP, AWS, Azure; popular databases e.g. SQL Server, MySQL, and the software development life cycle.

• Experience in risk management processes for medical technology development
• Experience in implementation/maintenance of a quality management system
• Experience in ISO13485 / IEC62304 audit is highly advantageous
• Experience in project coordination, technical project management, and/or technical documentation implementation/maintenance is desirable
• 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
• Strong problem-solving skills and technical writing skills
• Meticulous, detail-oriented, responsible and self-motivated