Senior Systems Engineer

Systems Engineer – Medical Devices Perth, WA | 12-Month Contract

$140K–$150K + Super
4 Days On-Site | Thursday WFH
Relocation Support Available

The Opportunity An exciting opportunity is available for an experienced Senior Systems Engineer to join an innovative organisation developing complex medical technology in Perth.

This is a highly cross-functional position requiring a genuine “whole-product” systems engineering mindset. You’ll work across multidisciplinary technologies spanning electronics, mechanical systems, embedded systems, software/firmware and medical-device development, connecting technical requirements with clinical, regulatory, quality and manufacturing considerations.

Importantly, we’re looking for a finisher – someone who has worked through the complete medical-device product development lifecycle and has contributed to a product that successfully progressed through a regulatory submission or approval process, such as the FDA or another recognised regulatory authority.

The underlying position has organisation-wide responsibility for maintaining the whole-product view across requirements, architecture, interfaces, risk controls, integration, V&V, design transfer and lifecycle changes. 

Key Responsibilities You will provide systems engineering leadership across multidisciplinary product development activities, including:

• Lead systems engineering and technical integration across complex medical-device programmes
• Define and maintain user needs, design inputs, system requirements and interface requirements
• Own system-level architecture, functional decomposition and interface definitions
• Manage interfaces across electronics, firmware, software, mechanical components, sensors, manufacturing processes and clinical systems
• Maintain end-to-end requirements traceability through design, risk controls and V&V
• Identify system-level technical risks, dependencies, evidence gaps and integration challenges
• Lead cross-functional system integration and technical decision-making
• Work closely with Engineering, Clinical, Regulatory, Quality, Manufacturing and external partners
• Support technical troubleshooting and resolution of complex system-level issues
• Contribute to design reviews, configuration management and change control
• Support design transfer, manufacturing scale-up and product lifecycle activities
• Provide systems engineering guidance and mentorship across multidisciplinary teams

The role specifically requires integration across biosensors, electronics, firmware, software, mechanical components, manufacturing, clinical workflows and external systems.

Verification, Validation & Risk You will play a key role in ensuring the product is technically and regulatorily ready, including:

• Defining and coordinating system verification and validation strategies
• Establishing test methods, configurations, acceptance criteria and traceability
• Ensuring product-level V&V readiness across engineering functions
• Leading system-level hazard and failure-mode identification
• Maintaining alignment across risk management, requirements, architecture, V&V and post-market information
• Assessing product changes for system-wide technical and regulatory impact
• Supporting investigation and resolution of anomalies
• Ensuring appropriate evidence is available to support regulatory submissions

About You
For this particular appointment, we’re looking for a senior, hands-on engineer with at least 7 years of full-time professional engineering experience.
You will ideally bring:

• Minimum 7 years' full-time engineering experience
• Strong commercial experience within the medical device industry
• Demonstrated systems engineering or technical integration experience
• Experience across multidisciplinary products incorporating electronics, mechanical engineering, firmware/software and embedded systems
• Strong understanding of medical-device design controls
• Experience with requirements management and end-to-end traceability
• Strong understanding of risk management, verification and validation
• Experience with design transfer, configuration management and change control
• Ability to work effectively across Engineering, Quality, Regulatory, Clinical and Manufacturing functions
• Strong analytical, technical problem-solving and communication skills
• Bachelor’s degree or higher in Systems Engineering, Biomedical Engineering, Electronics, Mechanical Engineering, Software Engineering or a related discipline

The JD also calls for practical knowledge of frameworks including ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366-1 and FDA design-control expectations. JD - Systems Engineer - Organis…
Medical Device Experience Medical device experience is strongly preferred and will be prioritised.
Candidates from adjacent highly regulated or safety-critical industries may also be considered where they can demonstrate highly transferable systems engineering, product development, V&V and regulatory experience.
Regulatory & Product Approval Experience A key requirement is experience taking a complex product through the later stages of development and towards successful regulatory submission or approval.
We’re particularly interested in engineers who have:

• Contributed to a product that successfully reached regulatory submission or approval
• Supported FDA or other recognised regulatory submissions
• Worked through product-level V&V and design transfer
• Developed or maintained technical evidence supporting regulatory submissions
• Demonstrated the ability to drive technical activities through to completion rather than working solely within early-stage R&D

This aligns closely with the JD's requirement for product-level V&V, design transfer and regulatory submission evidence. JD - Systems Engineer - Organis…
Location & Working Arrangements �� Perth, WA
This position requires a strong on-site presence due to the hands-on and cross-functional nature of the work.

• Monday–Wednesday: On-site
• Thursday: Work from home available
• Friday: On-site
• Remote working outside this arrangement is not available
• Interstate candidates willing to relocate to Perth are encouraged to apply
• Approximately $4,000 relocation assistance may be available for the right candidate, subject to an agreed clawback arrangement

The position itself is based in Malaga, WA. 
Package & Contract $140,000–$150,000 + Super
This position will initially be offered as a 12-month contract.

Interview Process The recruitment process will involve:

1. Initial introductory discussion
2. Round 1 – Written Technical Assessment covering skills-based and behavioural scenarios
3. Round 2 – Technical Interview
4. Round 3 – CEO Interview

Interested? If you’re an experienced Systems Engineer with a strong medical-device background who has seen complex products through the full development lifecycle and contributed to successful regulatory submission or approval, we’d like to hear from you.

This opportunity will particularly suit someone who enjoys being the technical link between systems, electronics, mechanical engineering, software/firmware, quality, regulatory and manufacturing and who knows how to drive complex products through to completion.

Apply now with your CV for a confidential discussion.