Description:
Our client is looking for a VP of Operations responsible for building and scaling the operational foundation of the company as the company transitions from pivotal clinical development to disciplined growth, with a strong near-term focus on supporting US market entry.
Client has 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 VP Operations ensures the Company can reliably, safely, and compliantly deliver its integrated hardware and software medical technology at increasing scale. This role owns operational strategy, manufacturing and supply chain execution, quality systems, cybersecurity operations, and organisational readiness, translating company strategy into executable plans while managing risk, cost, and complexity.
This individual will bring strong commercial acumen and experience to ensure close alignment between operational readiness, commercial rollout, and U.S. market execution.
Responsibilities
Operational strategy and scale-up execution
- Translate company strategy and commercial milestones into clear, executable operational plans, capacity models, and budgets, incorporating in-house and contract manufacturing strategies.
- Sequence operational readiness for U.S. establishment and early commercial execution, balancing speed, risk, and cash burn in partnership with the CEO, CFO, and Executive Leadership Team.
- Define, track and own internal and Board reporting on operational readiness metrics to support informed decision-making.
Hardware operations, manufacturing, and supply chain
- Design and scale manufacturing and supply chain models.
- Lead design transfer, manage design changes, and oversee configuration management to ensure seamless progression from development to manufacturing while maintaining compliance and product integrity
- Establish demand planning, scheduling and logistics.
- Manage supplier performance and continuity.
- Drive Cost of Goods optimisation.
- Own inventory management, field logistics, and distribution.
- Assist with design and rollout of Enterprise Resource Planning Manufacturing modules.
- Ensure manufacturing capacity, and service readiness are aligned with early commercial commitments and realistic delivery timelines.
- Establish and manage the customer feedback and service function in collaboration with the Head of Quality
Cybersecurity and connected-device operations
- Own cybersecurity, data protection (HIPAA/ GDPR) and Cloud Infrastructure operations.
- Establish vulnerability management and incident response, including Business Continuity and Disaster Recovery Plans.
- Partner with Engineering, Quality, and Regulatory teams to ensure cybersecurity risks are proactively managed, monitored, and reported.People, organisation, and leadership.
- Build and lead a high-performing operations organisation.
- Design scalable organisational structures and clear operational interfaces.
- Develop leadership capability and succession plans.
- Foster a disciplined yet agile culture appropriate for regulated medical devices.
- Ensure the operations organisation is structured to support increasing commercial focus and customer-facing activity.
Risk, governance, and operational discipline
- Key executive owner of operational and commercial risk, including identification and management of risk across the organisation.
- Own the Quality Management System.
- Process validation and transfer.
- Manage operational and capital budgets.
- Provide clear reporting to the CEO and Board.
- Vendor qualification and oversight
Qualifications
Essential
- Suitable backgrounds include Engineering, Business, or related fields. Bachelor’s degree required, MBA and/or advanced degree (Masters or PhD) preferred.
- Significant experience (typically 12+ years) in operations, manufacturing, supply chain, or related leadership roles within MedTech or regulated medical device companies.
- Demonstrated success scaling a hardware plus software medical product from late-stage development or early commercial use into broader market deployment, ideally including US entry.
- Strong, practical understanding of quality and regulatory frameworks for Class III Devices and how they translate into operational systems in a growing company.
- Proven ability to build teams, systems, and processes suitable for scale while maintaining compliance and reliability.
- Experienced in partnering closely with commercial leaders to align operational capacity with sales pipelines, customer onboarding, feedback/ service function and early adoption milestones.
Desirable
- Experience operating in venture-backed or growth-stage environments where operational leaders directly support early commercial execution and customer adoption.
- Exposure to US FDA inspections, audits, or post-market operations.
- Experience supporting geographically distributed teams and international expansion including early-stage market entry and customer rollout.
Personal Attributes
- Execution-focused: Translates strategy into action and results while understanding the commercial impact of operational decisions.• Risk-aware: Balances pace with quality, safety, and compliance.
- Collaborative leader: Works effectively across Commercial, Product, Engineering, and Clinical functions.
- Mentor and builder: Invests in developing people, teams, and long-term company capability.
- Structured and pragmatic: Builds systems that work now and scale later.
- Clear communicator: Provides concise, credible reporting to executives and Board.
- Resilient and adaptable: Comfortable operating in ambiguous, fast-changing environments typical of growth-stage companies.
- Decisive and practical: Makes clear, timely decisions in the face of incomplete information and competing priorities.
This position is based in Perth, Australia. Applicants must be local or willing to relocate.