At a Glance
- Tasks: Drive the development of innovative medical devices from design to manufacturing.
- Company: Akeeko Medical, an Australian-owned leader in medical technology.
- Benefits: Competitive salary, collaborative team environment, and career growth opportunities.
- Other info: Join a small, dynamic team with a focus on innovation and regulatory excellence.
- Why this job: Be a key player in revolutionising urology technology and making a real-world impact.
- Qualifications: 3+ years in medical device engineering and strong understanding of product development.
The predicted salary is between 82800 - 101200 $ per year.
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.
Enquiries to Peter Kiploks at PEK Human Systems on 0425 742 ***. Please email your application and resume to *****@pekhumansystems.com.au quoting PK2693. Applications close Monday 12 October 2026.
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Medical Device R&D Engineer: Design Transfer & V&V in Melbourne employer: PEK Human Systems
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