• Lead and manage manufacturing operations to ensure efficient production of high-quality medical devices in compliance with regulatory standards.
• This role involves overseeing production teams, driving continuous improvement, collaborating cross-functionally to meet business goals, and ensuring day-to-day production safety, quality, delivery, and cost targets are met.
• On-site role in a cleanroom and controlled manufacturing environment. Some travel may be required (less than 5%).

• Lead daily production activities, ensuring safety, quality, delivery, and cost targets are met.
• Manage and develop production supervisors, team leads, trainers, and operators, fostering a high-performance culture.
• Manage production planning, targets, and scheduling to meet customer demand, including warehouse activities.
• Ensure compliance with ISO 13485, FDA, and other relevant regulatory standards.
• Collaborate with Engineering, Quality, and Supply Chain to resolve production issues and implement process improvements.
• Monitor KPIs and drive continuous improvement initiatives using Lean and Six Sigma methodologies.
• Support new product introductions and technology transfers into manufacturing.
• Lead audits and inspections related to production operations.
• Leads Gemba walks in their area focusing on compliance to H&S, Quality & Production standards through regular review processes and frequent line walks

Ideally you will have:

• Bachelor’s degree in Engineering, Manufacturing, or related field.
• 5+ years of experience in medical device or regulated manufacturing industry.
• Strong knowledge of GMP, ISO 13485, and FDA regulations.
• Proven leadership and team development skills.
• Experience with Lean Manufacturing, Six Sigma, and continuous improvement tools.
• Excellent communication, problem-solving, and organizational skills
• Experience with ERP systems (e.g., IFS, SAP, Oracle).
• Strong interpersonal skills – holding team accountable, emotional intelligence.
• Ability to influence, negotiate and drive changes.

For more on this contact Regina at HERO 086 0100903 or jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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