Lead System Engineer - Medical Devices

Lead Systems Engineer, Medical Devices

Location: Melbourne, Australia

$140,000 - 175,000 + Super - Open to discussion - DOE

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

Systems Engineering

• 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 14971, 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 820.30) and relevant IEC/ISO standards (e.g. IEC 60601, IEC 62304, ISO 13485)
• 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 13485, ISO 14971, IEC 60601, and IEC 62304
• Experience leading or heavily contributing to at least one full device development cycle through to regulatory clearance or approval
• Strong 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)

Please reach out to [email protected] for more info