
Posted 20 hours ago
Mechanical Engineer
ResMed
Requirements
Tertiary qualification in Mechanical, Mechatronics, or Biomedical Engineering, Minimum 2 years of related experience, Experience in product development, 3D CAD modelling experience, Knowledge of DFMEA and regulatory requirements (ISO/FDA)
Skills
CREOCADANSYSFEACFD
About the role
Responsibilities
- Develop innovative medical devices from concept to production, ensuring designs meet marketing, patient, and usability requirements
- Take responsibility for component development with a holistic view of impact on end users and customers
- Assess and mitigate product risks using processes such as DFMEA
- Build prototypes using additive manufacturing and hand tools
- Design and perform verification and validation testing to ensure products meet specifications under various operating conditions
- Solve complex design problems using a combination of analysis and empirical methods
- Document all design development and testing activities accurately and completely
- Work within regulatory frameworks including ISO, FDA, and internal Quality Management Systems
- Collaborate with multidisciplinary teams including electrical, systems, software, and manufacturing engineers
Requirements
- Tertiary qualification in Mechanical, Mechatronics, or Biomedical Engineering
- Minimum 2 years of related engineering experience
- Proven experience in a product development role, preferably within medical devices or a highly regulated industry
- Proficiency in 3D CAD modelling (experience with Creo is a plus)
- Strong understanding of DFMEA and regulatory requirements (ISO/FDA)
- Excellent communication skills and ability to work effectively within a team
Preferred Qualifications
- Experience with ANSYS FEA or CFD
- Experience designing injection moulded components
- Ability to operate with a high level of autonomy while interacting with clinical and regulatory affairs
About the Company
ResMed creates life-changing health technologies that empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices, and intelligent software make home healthcare more personalized, accessible, and effective.
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ResMed · Sydney
