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Medical Technology Specialist

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Singapore beBeeMedical Full time $90,000 - $120,000
Medical Technology Innovation Specialist

You will be part of a team that implements risk management best practices in innovation projects aimed at adoption and commercialisation.

This role combines project coordination, quality management system implementation, risk assessment, and technical writing. You will ensure compliance with quality, regulatory, and organisational policies while supporting required record-keeping and documentation.

Responsibilities:

  • Establish processes and implement risk management best practices in innovation projects aimed at adoption and commercialisation.
  • 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, including validating clinical needs and advising on regulatory, quality, and risk requirements.
  • Perform risk assessments of proposed solutions with consideration of regulatory requirements; conduct clinical need filtering and de-risking.
  • Ensure compliance with quality, regulatory, and organisational policies and maintain required documentation.
  • Manage project tasks related to grants: recommend grants, ensure timely completion of milestones, and meet KPIs.
  • Contribute to project coordination, quality management system implementation, risk assessment, and technical writing.

Requirements:

  • 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.
  • Experience in implementation/maintenance of a quality management system.
  • Experience in ISO13485 / IEC62304 audit is highly advantageous.
  • Experience in the software development lifecycle is highly advantageous.
  • Experience in project coordination, technical project management, and/or technical documentation implementation/maintenance is desirable.

Key Qualifications:

  • 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.