Development Engineer

PEK Human Systems; City of Melbourne; On-site; AUD 90,000 - 125,000; Full time

Job summary

Akeeko Medical in Australia is seeking a broadly talented engineer to drive the development of medical device projects from design through transfer to manufacturing, with emphasis on rigorous documentation and compliance.

You will work within the ISO 13485 framework, supporting V&V, prototyping, and contractor management, ensuring design history files meet regulatory expectations. A related engineering qualification and 3+ years in medical devices are preferred.

Qualifications

• Knowledge of GD&T and product development lifecycle within medical devices.
• Familiarity with ISO 13485 quality systems and regulatory submissions.
• Experience with design transfer, V&V, and documentation for regulatory compliance.

Responsibilities

• Drive queued R&D projects from design through transfer to manufacturing.
• Develop and maintain technical documentation and design history files under ISO 13485.
• Ensure compliance with ISO 14971, TGA and FDA standards where applicable.

Skills

GD&T

ISO 13485 knowledge

Regulatory knowledge (TGA/FDA)

Design transfer

Product development lifecycle

Documentation skills

Medical devices experience

Education

Engineering degree

Job description

Akeeko Medical is an Australian-owned scientific and medical industry collaboration, currently navigating Australian and US regulatory submissions on a pathway to commercialisation in 2027 of an innovative medical device technology specific to urology conditions. A new role has opened up in this small team for a broadly talented engineer to drive the development path of devices through the design process and into manufacturing transfer; ensuring impeccable technical documentation for a range of stakeholders. Location: Fairfield.

Reporting to the GM Engineering & Manufacturing, you will be responsible for the development of queued R&D projects (product iterations) through to design transfer. Stages such as prototyping, testing and design V&V within ISO 13485 framework are underpinned by your specific product requirements, scopes of work and acceptance criteria for the contractors, rigorous evaluation and approval process, as well as ownership of the design history and technical files' content. Contributing in accordance with ISO 14971, TGA and FDA standards will also be required.

In this role, you will become Akeeko's internal, technical subject-matter expert. Knowledge and understanding of GD&T is required, however this is not a hands-on CAD position.

The incumbent requires practical knowledge of the product development cycle and ideally experience (3 yrs +) gained in medical devices. This will suit an engineer who can match stringent controls with commercial objectives. Both effective collaboration and independent thinking are imperative given the scope of work and decision-making authority of this role. A related engineering qualification is anticipated.

Applications close Monday 12 October 2026.