PRODUCTION MANAGER

OncoRes Medical was founded at the intersection of medicine, science and humanity to improve the accuracy of breast-conserving surgery and eliminate the physical, psychological and economic burdens associated with repeat operations.

Our unique, informal culture champions vision, restlessness and humanity. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work restlessly, pioneering change to re-imagine the world, while remaining grounded in our commitment to science and quality.

Our passion for helping patients focuses us on the patient. We believe that all breast cancer patients deserve the opportunity to move beyond their breast cancer surgery knowing that all the cancer has been removed, the first time. In everything we do, we are thinking about how we can inch closer to a world free from re-excisions... We are going BEYOND BREAST CANCER.

Overview:

We are seeking a skilled and highly motivated Production Manager to establish and lead our production capability as we transition from product development to regulated manufacturing.

This role will work closely with engineering, quality, and operations teams to solve problems and deliver outcomes. The role will be critical in supporting upcoming manufacturing runs, while laying the foundation for scalable, compliant production.

Reporting to the VP Technology, the Production Manager will take ownership of early production operations, including process development and build execution. The role will also play a key part in design transfer, supplier readiness, and production system development, ensuring alignment with ISO 13485 and FDA regulatory requirements.

We are looking for someone who can operate across new product introduction and early production, helping to address immediate production challenges while building capability for long-term manufacturing success.

Based in Nedlands, this role is offered as a 1.0 FTE fixed-term contract for 12 months, with the possibility of extension.

Responsibilities:

Production Readiness: Work with Facilities and Infrastructure Lead to ensure manufacturing environments, equipment, materials, and personnel are ready to support production activities.
Production Execution: Lead and develop a dedicated production team capable of supporting validation, clinical, and commercial manufacturing activities.

Design Transfer Support: Lead manufacturing transfer activities from Development into Production while providing support to ensure products are manufacturable, scalable, and support future commercial deployment.

Manufacturing Processes: Establish manufacturing methods, work instructions, training requirements, and production documentation.

Process Development & Validation: Develop and implement production processes, including documentation, risk assessments, and process validation activities.
Operational Oversight: Direct day-to-day production activities to meet safety, quality, delivery, and cost targets.

Process Improvement: Drive continuous improvement initiatives to enhance manufacturing efficiency, product quality, and production throughput.

Compliance and Quality: Ensure all manufacturing processes comply with ISO 13485, FDA, and other relevant regulatory requirements.

Documentation and Traceability: Ensure accurate production records are maintained, including device history records and manufacturing documentation.

Equipment & Systems: Establish control and visibility over production equipment, tooling, materials, and supporting manufacturing systems.

Supply Chain & Supplier Readiness: Support supply chain risk assessment and work closely with Quality on supplier qualification and ongoing supplier management.

Production Planning & Scheduling: Develop and manage production schedules, resource plans, and manufacturing priorities to meet project and commercial commitments.

Cross-Functional Support: Provide operational support to the broader technology team, particularly during periods of resource constraint.

Qualifications/Experience

Essential

Degree in Science, Engineering, or a related technical discipline, or equivalent experience.
Significant experience, 10–15 years, in a managerial position within the medical device or a similarly regulated manufacturing environment.
Demonstrated experience supporting design transfer, process validation, and manufacturing scale-up of regulated medical devices.

Strong working knowledge of Good Manufacturing Practice, ISO 13485, FDA 21 CFR Part 820 (Quality System Regulation).

Proven leadership ability, team development experience, and practical application of Lean Manufacturing and Six Sigma principles.

Excellent problem-solving, organisational, and professional communication skills.

Desirable

Experience with imaging, optical, diagnostic, or intraoperative medical devices.
Experience in start-up or growth-stage MedTech environments.

Personal Attributes

Hands-on operator: Comfortable working at both strategic and practical levels, including direct involvement in builds, setup, and problem-solving.
Builder mindset: Able to establish processes, teams, and systems from the ground up in a growing organisation.
Pragmatic and adaptable: Thrives in an environment with evolving priorities and incomplete information.
Execution-focused: Drives delivery while maintaining quality, safety, and compliance.
Clear communicator: Explains complex technical issues succinctly to non-technical stakeholders.

Benefits

Comprehensive and competitive remuneration package including access to the employee stock ownership plan.
A flexible and fun workplace where we understand that your life is more than your job.
A rare opportunity to work closely alongside world-class colleagues and mentors with many collective years' of experience in all aspects of medical device development and commercialisation.

OncoRes is committed to building and fostering an inclusive, diverse workplace. We believe the differing perspectives and experiences each of us brings inevitably increases innovation and teamwork, flowing into positive tangible outcomes.

How to apply

Applicants must have permanent working rights in Australia. Please apply online via SEEK and ensure you attach the following documents:

Cover letter addressed to the VP of Technology, outlining your suitability for the role
Resume

Applications close: Friday 26 June 2026

Please note applications will only be accepted through SEEK.