As Production Manager, you will be responsible for ensuring company production objectives are achieved for all commercial, NPD and technology transfer products. You will be a key member of the leadership team, collaborating cross-functionally to drive product quality, manufacturing efficiency, innovation, and commercial success.
With a hands-on approach, you will lead from the front, fostering a high-performance culture while ensuring compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and the Quality Management System
Responsibilities:
• Lead the Production Teams to achieve output, delivery, quality and cost targets.
• Manage, coach, motivate and develop the Production team.
• All Production planning to meet customer and company requirements.
• Implement smart metrics, tracking and reporting for manufacturing KPIs inc. line outputs, yields, scrap.
• Plan capacity and ensure adequate resources are in place to successfully deliver the production department goals.
• Drive continuous improvement plans in Production using lean manufacturing approach with focus on safety, quality, productivity and cost.
• Technology transfers to Production and implementing new products and technologies to high yield, scalable manufacturing.
• Implementation and completion of QMS documentation for Production.
• Provide design for manufacturing expertise for NPD process development teams.
• Demonstrated team building, problem solving, continuous improvement and cost reduction achievements in Production and related areas.
• Proven ability to blend strategic vision with a hands-on, problem-solving approach.
• Strong experience in operational excellence and lean manufacturing.
• Entrepreneurial mindset with a commercial awareness to align manufacturing with business objectives.
• Excellent communication and documentation skills.
• Ability to manage multiple priorities in a fast-paced production environment
Qualifications:
• Bachelor’s Degree in an engineering or technical discipline (or equivalent experience).
• 10+ years of progressive experience in medical device manufacturing, ideally within Class III implantable devices.
• Knowledge of quality standards including ISO 13485, MDR, and FDA Requirements.
• Proficient in process improvement tools such as Lean, Six Sigma (Green Belt is an advantage).
For a confidential discussion on the role and more information on the company please contact Chris O Toole
