Medical Device Engineer

5 days ago

Greater Sydney Area, Australia Affectable Sleep Full time $80,000 - $100,000 per year

About Affectable

Affectable is a Sydney-based neurotechnology company developing next-generation wearables that enhance the restorative function of sleep.

About the role

We are seeking a Medical Device Engineer to join our team. The role involves research and development of biomedical device components, supporting the transition of prototypes into manufacturing, and contributing to certification and compliance work.

Responsibilities

  • Conduct research and development activities related to biomedical device components, including design, fabrication, and testing
  • Manage and maintain laboratory equipment, materials, and records in accordance with Sydney Knowledge Hub requirements
  • Support product development including design reviews, manufacturing preparation, and quality assurance
  • Contribute to regulatory and certification activities for medical and consumer devices
  • Provide project management support including progress tracking, documentation, and coordination with internal and external stakeholders

Requirements

  • Degree in Biomedical Engineering
  • Hands-on experience in device research and development, prototyping, or testing
  • Familiarity with medical device standards, manufacturing processes, or certification pathways
  • Strong analytical and problem-solving skills
  • Effective communication and ability to work as part of a team

Desirable

  • Experience with silicone, polymers, or wearable sensor development
  • Prior exposure to ISO 13485, IEC 60601, or similar regulatory frameworks
  • Background in neuroscience or sleep technology

Salary

$78,000 per year plus superannuation

Hours

Full-time, 38 hours per week

Location

Sydney Knowledge Hub, University of Sydney, NSW

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