The Production Manager will lead day-to-day manufacturing operations within a regulated medical device environment, ensuring safe, efficient, and compliant production while supporting the organisation's growth and scaling objectives.
This role is responsible for driving operational excellence through Lean manufacturing principles, robust KPI development, effective people management, and successful technology transfer from development into high-volume manufacturing.
The ideal candidate is a hands-on leader who thrives in a fast-growing environment, balances strategic thinking with execution, and builds high-performing teams. This role can grow swiftly withing the organisation with the growth projections and performance.
Key Responsibilities
Manufacturing & Operations
* Lead and manage all production activities to meet safety, quality, delivery, and cost objectives.
* Ensure manufacturing operations comply with regulatory and quality requirements (ISO 13485, FDA QSR, EU MDR).
* Develop and execute production plans aligned with business demand, capacity, and scaling requirements.
* Collaborate closely with Quality, Engineering, Supply Chain, and R&D to ensure smooth operations.
Lean Manufacturing & Continuous Improvement
* Champion Lean manufacturing principles (e.g. 5S, Kaizen, Standard Work, Value Stream Mapping).
* Drive continuous improvement initiatives to improve productivity, yield, throughput, and cost efficiency.
* Lead problem-solving activities using structured methodologies (A3, root cause analysis, CAPA).
* Embed a culture of operational excellence and employee engagement.
KPI Development & Performance Management
* Define, implement, and track production KPIs (e.g. OEE, output, scrap, cycle time, on-time delivery).
* Use data-driven insights to identify trends, risks, and improvement opportunities.
* Communicate performance clearly to senior management and shop-floor teams.
* Ensure accountability and ownership of results across the production organisation.
People Leadership & Development
* Lead, coach, and develop a team of supervisors, team leads, and operators.
* Build a positive, inclusive, and high-performance culture with a strong focus on safety and quality.
* Manage recruitment, onboarding, training, performance reviews, and succession planning.
* Drive employee engagement and foster continuous skills development.
Technology Transfer & Scale-Up
* Lead and support technology transfer activities from R&D or external partners into manufacturing.
* Ensure manufacturing processes are robust, validated, and scalable for commercial production.
* Collaborate with Engineering and Quality on process validation, equipment qualification, and documentation.
* Support new product introductions and capacity expansion initiatives.
Key Requirements
Experience
* 7+ years' experience in manufacturing within the medical device or highly regulated industry.
* Proven experience in a Production Manager or similar leadership role.
* Strong track record of implementing Lean manufacturing and continuous improvement initiatives.
* Hands-on experience with technology transfer and manufacturing scale-up.
* Experience developing and managing production KPIs in a growth environment.
Skills & Competencies
* Strong people leadership and communication skills.
* Data-driven mindset with strong problem-solving capability.
* Ability to operate effectively in a fast-paced, scaling organisation.
* Excellent planning, organisational, and decision-making skills.
* Comfortable working cross-functionally and influencing at all levels.
Education
* Degree in Engineering, Manufacturing, Operations, or a related discipline.
* Lean certification (e.g. Lean Six Sigma Green/Black Belt) is highly desirable.
What Success Looks Like
* Consistent achievement of production targets while maintaining regulatory compliance.
* Measurable improvements in efficiency, quality, and cost through Lean initiatives.
* Strong, engaged, and capable production teams.
* Successful and timely technology transfers supporting business growth.
For a confidential discussion on the role please contact
Chris O Toole.