Production Manager MedTech

UroMems; Fontanil-Cornillon; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

UroMems in Fontanil-Cornillon, FR, seeks a Production Manager to lead manufacturing of implantable medical devices, ensuring safety, quality, and compliant operations. You will own shop-floor execution, drive continuous improvement, manage a cross-functional team, and partner with Industrialization, Quality, and Regulatory Affairs to scale production up.

The role requires 10+ years in manufacturing with at least 3 years of people management, knowledge of ISO 13485, and experience in regulated

Qualifications

• 10 years minimum experience in manufacturing, production engineering, or operations.
• Minimum 3 years of people management experience.
• Experience in regulated medical devices or similar environment.
• Strong knowledge of ISO 13485 and regulatory manufacturing requirements.
• Experience with audits, CAPA, and controlled documentation.

Responsabilités

• Lead daily production execution and translate the plan into priorities.
• Ensure compliance with ISO 13485 and regulatory requirements; prepare for audits.
• Define training needs and develop the production team with HR, Quality, and process owners.
• Monitor KPIs for safety, quality, delivery, and productivity; drive continuous improvement.

Connaissances

Team leadership

Lean manufacturing

Problem solving

Quality mindset

Formation

Engineering degree

Lean/Six Sigma

Outils

ERP/MRP

MES

Digital manufacturing

Description du poste

UroMems is developing innovative implantable medical technologies aimed at improving patients' quality of life. As we prepare for production scale-up and future commercialization, we are seeking an experienced Production Manager to lead our manufacturing operations and support industrial growth in a highly regulated medical device environment.

Your Mission

As Production Manager, you will own the day-to-day execution of manufacturing activities and ensure medical devices are produced safely, reliably, efficiently, and in full compliance with the Quality Management System, approved manufacturing documentation, ISO 13485 requirements, and business priorities.

You will be responsible for shop-floor discipline, production performance, team leadership, lot execution readiness, and operational escalations, while fostering a strong quality and patient safety culture.

Working closely with Industrialization, Quality, Supply Chain, Maintenance, Logistics, and R&D teams, you will also support production ramp‑up activities and ensure the successful transition from validated processes to routine manufacturing.

What you will do

Production Operations & Shop-Floor Management

• Lead daily production execution and translate the production plan into clear operational priorities.
• Coordinate manufacturing activities, workload allocation, team briefings, and escalation management.
• Monitor capacity, bottlenecks, work-in-progress, and production constraints while implementing recovery plans when needed.
• Ensure products and production lots are manufactured, documented, controlled, and prepared for quality review and release according to approved procedures.

Quality & Regulatory Compliance

• Ensure manufacturing activities comply with ISO 13485, internal quality requirements, and applicable medical device regulations.
• Maintain complete, accurate, and inspection-ready production documentation.
• Lead or support investigations related to deviations, non-conformities, and CAPA activities.
• Prepare production teams for audits and support audit responses and follow‑up actions.
• Ensure only trained and qualified personnel perform controlled manufacturing operations.
• Promote a patient‑safety‑first mindset in all production decisions.
• Lead, coach, and develop the production team.
• Define training and qualification needs in collaboration with HR, Quality, and process owners.
• Foster teamwork, accountability, effective communication, and structured problem solving.
• Support recruitment, onboarding, competency development, and succession planning.

Performance & Continuous Improvement

• Define and monitor KPIs related to safety, quality, delivery, productivity, cost, and people development.
• Analyze production performance and lead improvement initiatives focused on yield, throughput, capacity, and right‑first‑time performance.
• Implement Lean Manufacturing and visual management practices.
• Contribute to productivity and cost‑reduction initiatives while maintaining compliance and product quality.
• Support definition and execution of production ramp‑up strategies.
• Participate in industrialization and design transfer activities.
• Coordinate pilot lots, engineering builds, validation‑support activities, and initial production lots.
• Identify operational risks related to capacity, equipment, materials, training, quality, and product release readiness.
• Monitor ramp‑up KPIs and drive mitigation plans when required.
• Ensure smooth transfer of manufacturing processes from Industrialization to Production.
• Support production scale‑up decisions regarding staffing, equipment, facility layout, and productivity improvements.

Equipment, Resources & Manufacturing Environment

• Ensure production resources, tooling, equipment, and materials are available and compliant with requirements.
• Coordinate with Maintenance and Metrology to maintain equipment availability and calibration status.
• Ensure manufacturing areas operate according to cleanliness, contamination‑control, safety, and HSE requirements.
• Contribute to production budgeting, workforce planning, and investment planning.

What you bring

Education

• Engineering Degree or Master's Degree in Manufacturing, Mechanical, Industrial, Biomedical Engineering, or a related technical discipline.
• Certifications such as Lean Manufacturing, Six Sigma, Operational Excellence, or Project Management are a plus.

Experience

• 10 years minimum experience in manufacturing, production engineering, or operations.
• Minimum 3 years of people management experience.
• Experience within medical devices or another regulated manufacturing environment.
• Strong understanding of ISO 13485 and regulated manufacturing requirements.
• Proven experience managing production operations, ramp‑up activities, capacity planning, and shop‑floor performance.
• Experience with non‑conformities, CAPA, audits, training programs, and controlled manufacturing documentation.
• Experience working closely with Quality Assurance and Regulatory Affairs.
• Experience with implantable medical devices, cleanroom environments, electromechanical assembly, laser welding, soldering, cleaning, or packaging is a strong advantage.
• Experience implementing Lean Manufacturing, automation, ERP/MRP, MES, or digital manufacturing systems is highly desirable.

Languages

• Professional proficiency in both French and English (written and spoken).

Travel

Occasional travel within France and internationally.

What we propose:

• CDI contract
• Competitive salary and package
• International environment

All our positions are open to people with disabilities, provided they have the required skills.