Systems Engineer

An Australian medical device development company is strengthening its engineering team and is now hiring a Systems Engineer to be the technical thread that ties its development work together. You will make sure every design decision, test result, and safety consideration lines up into a product that can stand up to external approval.

In this role you will be the person who can explain, at any point, why the product is safe and performs as intended, and where the proof for that can be found. You will get involved early, sitting down with end users, researchers, and product owners to pin down what the product genuinely has to achieve, then turning that into clear targets the engineering teams can build and test against. As the design develops, you will be the first point of call for any proposed change, weighing up how it ripples through the hardware, software, production process, instructions for use, and approval commitments before anyone signs it off. You will get hands on with prototype and early production builds, deciding what goes into each one and what has to be ready before testing begins. You will maintain up to date architecture documentation showing how the electronics, firmware, software, and mechanical parts work together, written so an engineer from any background can follow it. You will think hard about how things could go wrong, including misuse by operators and problems with third party equipment, and plan testing so every safeguard is shown to work. Later in the cycle, you will manage a clean handover to production and production partners, and trace problems reported in service back to their source in the design. Much of the role is about bringing people with you. Research, engineering, quality, regulatory, and production teams each have their own priorities, and you will get them to agreed decisions without taking ownership away from the specialists. This is a senior individual contributor position for someone who has seen complex regulated products through to approval and knows what a complete, defensible approval file looks like. The engineering practices here are still taking shape, so it suits a hands on generalist who is comfortable switching between systems, electronics, and mechanical problems in the same week and who wants to help shape how the work is done rather than inherit a finished rulebook.

This is a full time role based in Perth, working onsite 4 days a week with 1 day from home. A relocation allowance is available for the right interstate candidate.

Key Responsibilities:

• Assemble and maintain the proof an approval body will review, so every test result links back to a target and every target links back to a genuine user need.
• Work with end users, researchers, and product owners early to agree what the product must achieve, and turn that into measurable targets engineers can design and test against.
• Act as the first point of call for proposed design changes, assessing how each one affects hardware, software, production, instructions for use, and approval commitments before it goes ahead.
• Get hands on with prototype and early production builds, deciding the contents of each build, the assembly sequence, and what must be ready before testing begins.
• Maintain up to date architecture documentation that engineers in any discipline can follow and use.
• Identify how the product could fail or cause harm, including misuse by operators and problems with third party equipment, and make sure each safeguard is built in and tested.
• Plan testing at every level, set clear pass criteria, and lead the investigation of unexpected results while keeping repeat testing proportionate.
• Manage a clean handover to production and production partners, and check that later process changes do not alter the product without anyone noticing.
• Bring research, engineering, quality, regulatory, and production teams to agreed decisions, without taking ownership away from the specialists.
• Introduce lightweight engineering practices and mentor colleagues so good systems habits spread across the team.

Requirements:

• Engineering degree in a mechanical, electrical, electronic, biomedical, mechatronic, or software discipline, or similar.
• At least 7 years of full time engineering experience, with a substantial part of it on medical devices.
• Broad technical grounding across systems, electronics, and mechanical engineering, enough to both question and support specialists in each area.
• Experience taking a complex product from early concept through build, test, and handover to production.
• Practical knowledge of medical device design control processes, ISO 13485, ISO 14971, and the associated product safety and software standards.
• Direct involvement in a product that has gained FDA or equivalent regulatory approval, with a clear sense of what an approval file needs.
• A senior, self directed profile, comfortable working as an individual contributor with a broad remit and no direct reports.
• A strong communicator who can persuade people with competing priorities to reach the same decision.

Desirable but not essential:

• Experience in a smaller or growing company where engineering practices are still being built.
• Practical exposure to electronic hardware and embedded systems, including compliance testing such as EMC.
• Use of structured modelling approaches such as SysML or MBSE.
• Experience with requirements management tools such as Jama, DOORS, Polarion, or similar.
• Exposure to cybersecurity or human factors work on a connected product.

Please reach out to harold@profoundpeople.com.au for more info