Job Description

About the Role

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We are looking for a Lead Systems Engineer to guide the technical and regulatory development of a recent 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.

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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.

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Key Responsibilities

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- 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
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- 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
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- Lead risk management activities in line with ISO 14971, including hazard analysis, FMEA, and risk mitigation tracking
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- Ensure full traceability across the V model, linking user needs, system requirements, design outputs, verification, and validation activities throughout development
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- Drive verification and validation planning early in the project, ensuring test methods are defined alongside requirements rather than after design is complete
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- Coordinate cross functional input from electronics, mechanical, software, and human factors engineering into a coherent system design
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Regulatory Guidance

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- 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
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- Ensure design and development activities align with FDA design control requirements (21 CFR 820.30) and relevant IEC/ISO standards (e.g. IEC 60601, IEC 62304, ISO 13485)
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- Prepare and review technical documentation required for regulatory submissions, audits, and design reviews
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- Act as the internal point of reference for regulatory and quality questions during day to day engineering work
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- Support interactions with regulatory bodies, notified bodies, or external consultants as needed
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Manufacturing Transition

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- Support the transition from design and prototyping through to manufacturing, ensuring design for manufacture and design for reliability principles are applied early
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- Work with manufacturing and quality teams to establish process validation and production readiness in line with regulatory requirements
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- Help resolve technical issues that arise during scale up, without compromising design intent or compliance
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Leadership

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- Provide technical leadership and mentorship to engineers across disciplines
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- Communicate technical and regulatory status clearly to leadership, balancing detail with clarity for non technical stakeholders
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- Contribute to project planning, helping ensure regulatory milestones are realistically reflected in overall timelines
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What We're Looking For

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- Significant experience as a systems engineer within the medical device industry, ideally spanning concept through to commercial manufacturing
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- Strong practical experience applying the V model systems engineering approach, including requirements decomposition, verification and validation planning, and traceability management
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- Deep working knowledge of FDA regulatory requirements for medical devices, including design controls, risk management, and submission pathways
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- Familiarity with relevant standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304
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- Experience leading or heavily contributing to at least one full device development cycle through to regulatory clearance or approval
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- Strong cross disciplinary understanding across electronics, mechanical, and software engineering
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- Excellent communication skills, comfortable guiding both engineers and leadership through complex regulatory considerations
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- Based in or willing to relocate to Melbourne
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Nice to Have

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- Direct experience with FDA submissions (510(k), De Novo, or PMA)
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- Experience with combination products or active implantable devices
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- Background in human factors engineering or usability testing for medical devices
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- Experience supporting international regulatory pathways beyond FDA (e.g. TGA, EU MDR)
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📌 Lead System Engineer - Medical Devices (Victoria)
🏢 ProFound People
📍 Victoria