Aurora Lifesciences are partnered with a fast-growing medical device company dedicated to developing and delivering innovative solutions that improve patient outcomes and quality of life. As they transition from development to full-scale manufacturing, they are seeking a highly capable Interim Manufacturing Manager who can help shape their production operations from the ground up.
The Opportunity
This is a pivotal role for a hands-on, results-driven professional with start-up medical device experience, a proven ability to build high-performing teams, and a track record of implementing ERP systems to enable efficient, compliant manufacturing. You will lead the establishment, optimisation, and scaling of our onsite production capability while ensuring compliance with all regulatory and quality standards.
Key Responsibilities
Manufacturing Operations Leadership-
* Oversee all onsite production activities to ensure quality, efficiency, and cost-effectiveness.
* Establish and maintain manufacturing processes, workflows, and equipment to meet demand.
Team Building & Leadership
* Recruit, train, and lead a multi-disciplinary manufacturing team.
* Foster a culture of accountability, safety, quality, and continuous improvement.
ERP Implementation & Optimisation
* Lead the selection, implementation, and integration of an ERP system to support manufacturing, inventory, and supply chain operations.
* Ensure ERP processes are aligned with regulatory requirements and production needs.
Regulatory Compliance & Quality
* Ensure manufacturing operations meet ISO 13485, FDA, and other applicable regulatory standards.
* Collaborate with Quality and Regulatory teams to maintain compliance and readiness for audits.
Capacity & Scalability
* Plan and execute manufacturing scale-up activities to meet commercial demand.
* Drive process improvements to optimise throughput, reduce waste, and improve yields.
Cross-Functional Collaboration
* Work closely with R&D, Quality, Supply Chain, and Engineering teams to ensure smooth product transfer from development to production.
Qualifications & Experience
* Proven leadership experience in manufacturing management within a medical device start-up or early-stage growth environment.
* Track record of building and leading high-performing teams in a manufacturing setting.
* Hands-on experience in implementing and managing ERP systems (e.g., SAP, Oracle, NetSuite, or similar).
* Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device manufacturing regulations.
* Experience in production planning, process validation, and lean manufacturing principles.
* Strong problem-solving, organisational, and decision-making skills.
* Excellent interpersonal and communication skills for effective cross-functional collaboration.
If you’re a hands-on manufacturing leader with the vision, technical expertise, and energy to establish world-class operations in a growing medical device company, we’d like to hear from you.
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