Medical Device Development Specialist

6 days ago


Sydney CBD, New South Wales, Australia IDE Group Full time
Medical Device Development Specialist

About the Job

At the IDE Group, we love working with our partners to build better futures, working on over 500 projects across the medical technology landscape.

We are seeking a Medical Device Development Specialist who will be responsible for ensuring quality is planned for and implemented in projects, satisfying project stakeholders to produce commercially successful results.

This role is in our Connected Care Business Unit where you will report directly to the Business Unit Director.

You will assist the Quality Manager in the management and improvement of the company's ISO 13485-certified Quality Management System, ensuring that quality requirements are met throughout Product Development projects.

Key responsibilities include:

  • Working within cross-functional teams to guide employees through new or improved methods to product development, by means of QMS processes.
  • Reviewing and approving engineering documentation to provide input on product development activities and direction to employees.
  • Ensuring appropriate engineering principles are applied throughout the development of medical devices by reviewing and analysing product development documentation.
  • Actively collecting, analysing data and information within product development projects and the QMS.

Required Skills and Qualifications:

  • A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.
  • Minimum 2 years experience working in medical device development projects in a functional leadership role.
  • Experience working in an ISO 13485-compliant QMS.
  • Understanding of key Medical Device standards including ISO 14971 and IEC 62366.

The Benefits:

  • Career progression and a strong mentoring program.
  • Flexible working options available.
  • Employee benefits including an employee assistance program.


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