About the Role
We are looking for a Lead Systems Engineer to guide the technical and regulatory development of a new medical device, from early concept through to full scale manufacturing.
This is a senior, hands on role for someone who can own the systems engineering approach while also acting as the team's guide through FDA regulatory requirements and the broader medical device development lifecycle.
You will work closely with electronics, mechanical, Firmware, and quality teams to ensure the product is designed, documented, and verified in a way that meets regulatory expectations at every stage, not bolted on at the end.
Key Responsibilities
Own the overall system architecture, requirements management, and design controls for the device across the full V model development lifecycle, from user needs through to system verification and validation
Translate user needs and clinical requirements into verifiable system and subsystem level requirements, ensuring each level of the V has a corresponding verification or validation activity
Lead risk management activities in line with ISO *****, including hazard analysis, FMEA, and risk mitigation tracking
Ensure full traceability across the V model, linking user needs, system requirements, design outputs, verification, and validation activities throughout development
Drive verification and validation planning early in the project, ensuring test methods are defined alongside requirements rather than after design is complete
Coordinate cross functional input from electronics, mechanical, software, and human factors engineering into a coherent system design
Regulatory Guidance




Guide the team through the FDA regulatory pathway appropriate to the device (e.g. 510(k), De Novo, or PMA), advising on strategy and documentation requirements from concept stage onward
Ensure design and development activities align with FDA design control requirements (21 CFR ******) and relevant IEC/ISO standards (e.g. IEC *****, IEC *****, ISO *****)
Prepare and review technical documentation required for regulatory submissions, audits, and design reviews
Act as the internal point of reference for regulatory and quality questions during day to day engineering work
Support interactions with regulatory bodies, notified bodies, or external consultants as needed
Manufacturing Transition
Support the transition from design and prototyping through to manufacturing, ensuring design for manufacture and design for reliability principles are applied early
Work with manufacturing and quality teams to establish process validation and production readiness in line with regulatory requirements
Help resolve technical issues that arise during scale up, without compromising design intent or compliance
Leadership
Provide technical leadership and mentorship to engineers across disciplines




Communicate technical and regulatory status clearly to leadership, balancing detail with clarity for non technical stakeholders
Contribute to project planning, helping ensure regulatory milestones are realistically reflected in overall timelines
What We're Looking For
Significant experience as a systems engineer within the medical device industry, ideally spanning concept through to commercial manufacturing
Strong practical experience applying the V model systems engineering approach, including requirements decomposition, verification and validation planning, and traceability management
Deep working knowledge of FDA regulatory requirements for medical devices, including design controls, risk management, and submission pathways
Familiarity with relevant standards such as ISO *****, ISO *****, IEC *****, and IEC *****
Experience leading or heavily contributing to at least one full device development cycle through to regulatory clearance or approval
Solid cross disciplinary understanding across electronics, mechanical, and software engineering
Excellent communication skills, comfortable guiding both engineers and leadership through complex regulatory considerations
Based in or willing to relocate to Melbourne
Nice to Have
Direct experience with FDA submissions (510(k), De Novo, or PMA)
Experience with combination products or active implantable devices
Background in human factors engineering or usability testing for medical devices
Experience supporting international regulatory pathways beyond FDA (e.g. TGA, EU MDR)
#J-*****-Ljbffr

📌 Lead System Engineer - Medical Devices (Melbourne)
🏢 ProFound People
📍 Melbourne