As Senior Manufacturing 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).