Benefits

• Competitive base salary + bonus
• Opportunity to lead and shape process validation from the ground up
• Work on innovative medical devices with a global reach
• Collaborative culture that values growth, learning and development

About the Company

This established medical device manufacturer is recognised for its technical excellence and ongoing product innovation. With a strong engineering capability and products distributed internationally, the business is expanding its New Product Introduction (NPI) team to support upcoming product launches and continuous improvement initiatives.


About the Opportunity

In this role, you will lead the process development and validation function for new and existing products. You will provide technical leadership and mentorship to a small engineering team, ensuring processes are robust, efficient and compliant with regulatory standards.


Duties

• Lead the process development & validation workstream across NPI projects
• Develop and execute validation protocols (IQ/OQ/PQ) from first principles
• Partner with R&D, Procurement and Manufacturing to ensure process readiness
• Support manufacturing scale-up and global technology transfer
• Implement DFM/DFMA and Lean Manufacturing principles
• Troubleshoot, identify root causes and drive continuous improvement
• Mentor engineers and uplift technical and validation capability
• Ensure documentation and regulatory deliverables are completed for launch readiness

Skills and Experience

• Degree-qualified in Mechanical, Manufacturing or related Engineering field
• Experience working within the medical device or pharmaceutical industry is essential
• Strong process validation expertise, including development of processes (IQ/OQ/PQ)
• Demonstrated leadership and team mentoring skills
• Hands-on, analytical and solutions-focused approach
• Strong stakeholder management and collaborative
• Excellent communicator and problem solver
• Full Australian working rights required for this role

Culture

A collaborative and technically driven team culture that values accountability, open communication, and continuous improvement. Leaders foster trust, support growth, and encourage engineers to take ownership and innovate.


How to Apply

Click Apply Now and provide us with a copy of your updated CV or contact Michelle Vermaak on 02 8877 8760 for a confidential discussion.