Head of Engineering

Our client is looking for a Perth- based dynamic and experienced individual to lead all Product Development activities. They have developed an intraoperative imaging system that combines optical coherence tomography (OCT) and elastography to assess tissue microstructure at a scale and resolution comparable to histology. Think of it as translating the surgeon's sense of touch into a microscale image, giving surgeons "digital palpation" capabilities during surgery. The Head of Engineering is the Company’s senior engineering authority, accountable for engineering execution, system integrity, and delivery of compliant, high-quality products to market. As Head of Engineering, you will be an integral member of the senior leadership team, providing strategic direction, day-to-day technical leadership and responsibility for all the company’s product development activities. Working with the CEO and Executive team, the Head of Engineering will ensure that the Company’s products are developed to meet the changing needs and interests of the users and comply with all national and international regulations, consistent with the Company’s strategic plan and commercial objectives. The Head of Engineering assists with strategic business planning/execution, product innovations, sub-contractor and supplier co-ordination, and customer feedback. If you have Medical Device development experience and want to use your expertise to build a novel, disruptive medical product that will impact the lives of millions of people around the world, this could be the job for you! Responsibilities

Engineering leadership and execution

Provide senior leadership for all engineering and product development activities, including internal teams and external development partners. Own day-to-day execution of product development across software, hardware, systems engineering, and research activities. Ensure engineering execution aligns with the Company’s strategic plan, product roadmap, and clinical objectives. Ensure effective knowledge transfer and protection of intellectual property from research and development partners. Support expansion of the Company’s intellectual property and product portfolio in collaboration with the executive team. Product development and delivery

Translate product and technology strategies into clear, executable development plans, schedules, and resourcing models. Deliver products on time, within budget, and to high standards of quality, performance, and reliability Drive design for manufacturability, reliability, serviceability, and scalability across the product lifecycle. Proactively identify technical, schedule, and delivery risks and implement effective mitigation strategies. Maintain awareness of advances in medical technology, particularly in surgical oncology, and ensure product development protects a sustained competitive advantage. Regulatory and quality partnership

Partner closely with Quality and Regulatory Affairs to ensure compliance with applicable standards and regulations, including FDA QSR (21 CFR Part 820), ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971, and EU MDR. Ensure engineering documentation supports design controls, verification and validation activities, and regulatory submissions for a Class III medical device. Oversee and coordinate external development partners, suppliers, and contractors to ensure quality, compliance, and delivery expectations are met. People, capability, and culture

Lead, mentor, and develop a high-performing, multidisciplinary engineering organisation. Establish and maintain best-practice engineering processes appropriate for regulated medical device development. Foster a culture of technical rigour, accountability, collaboration, and continuous improvement. Financial and resource management

Work with the VP Operations and CFO to develop and manage annual engineering and product development budgets. Monitor expenditure and resource utilisation to ensure efficient and effective delivery of development programs. Ensure engineering activities are delivered within approved budgets and timelines. Stakeholder relationships Report directly to the VP Technology (Executive level position) and operate as a key member of the Senior Management Team. Collaborate closely with Quality and Regulatory, Manufacturing, Clinical, Customer Support, and other internal teams. Provide technical input to executive decision‑making and Board discussions as required. Authority and delegation

Exercise financial authority in accordance with the Company’s approved financial delegations. Act as a delegated technical authority in line with the Engineering and Technical Delegations Procedure. Qualifications

Degree in Engineering or related technical discipline (biomedical, electrical, mechanical, software, or systems). Significant experience (typically 12–15+ years) in medical device engineering, including leadership of complex, regulated products through the full development lifecycle. Demonstrated success leading development of integrated Class III hardware and software medical devices from concept through verification, validation, and commercial release. Strong, practical knowledge of regulated medical device development, including design controls, risk-based development, and verification and validation. Hands‑on experience with relevant standards and regulations, including IEC 60601, IEC 62304, IEC 62366, ISO 14971, ISO 13485, FDA QSR (21 CFR Part 820), and EU MDR. Proven ability to provide system‑level technical leadership, make trade‑offs, and act as final engineering authority on complex technical decisions. Experience leading and coordinating external development partners, suppliers, and contractors. Experience with imaging, optical, diagnostic, or intraoperative medical devices. Experience supporting clinical deployments, trials, or early commercial use in hospital or surgical environments. Exposure to manufacturing transfer, scale‑up, and design for manufacturability. Experience in start‑up or growth‑stage MedTech environments. Postgraduate qualification or MBA exposure (advantageous but not essential). Personal Attributes

Technically authoritative: Credible as the senior engineering voice with engineers, clinicians, executives, and external partners. Execution-focused: Drives delivery while maintaining quality, safety, and compliance. Systems thinker: Able to balance hardware, software, usability, clinical workflow, and regulatory considerations. Decisive and pragmatic: Makes clear, timely decisions in the face of incomplete information and competing priorities. Collaborative leader: Works effectively across Product, Clinical, Quality, Operations, and Commercial functions. Mentor and builder: Invests in developing people, teams, and long‑term engineering capability. Clear communicator: Explains complex technical issues succinctly to non‑technical stakeholders. Resilient and adaptable: Comfortable operating in ambiguous, fast‑changing environments typical of growth‑stage companies. This position is based in Perth, Australia. Applicants must be local or willing to relocate.

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