Mechanical Engineer – Medical Device Development

About the role

The Devices Mechanical team creates innovative medical products that improve health outcomes worldwide. As a Mechanical Engineer you will design, develop and verify high‑volume respiratory devices, collaborating with cross‑functional engineers and designers.

Key responsibilities

• Design components with consideration for marketing, patient needs, human factors, therapy performance, environmental impact and manufacturability.
• Develop and assess DFMEA to mitigate product risks.
• Build prototypes using additive manufacturing, hand tools and other techniques.
• Design and execute verification and validation tests to ensure compliance with specifications.
• Analyse design problems using both analytical and empirical methods.
• Document development and testing activities accurately.
• Work within ISO, FDA and ResMed Quality Management System requirements.
• Collaborate autonomously with marketing, manufacturing, clinical and regulatory teams.

Required profile

• Tertiary qualification in Mechanical, Mechatronics, Biomedical Engineering or equivalent.
• Minimum 2 years of product development experience, preferably in medical devices or other highly regulated industries.
• Strong analytical mindset, curiosity and excellent communication skills.
• Team‑player attitude.

Required skills

• 3D CAD modelling (Creo or any CAD package).
• Experience with DFMEA.
• Prototype construction, including additive manufacturing.
• Product testing, verification and validation.
• Knowledge of ISO and FDA regulatory requirements.
• Familiarity with ANSYS FEA or CFD (desirable).
• Experience designing injection‑moulded components (desirable).