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| Medical Device Industrialization & Operation Manager |
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As part of a major initiative to industrialize and manufacture high quality, reliable and innovative medical devices, the Medical Device Industrialisation and Operation manager will play a pivotal role in the industrialization activities of new medical devices coordinate packaging and labeling whilst ensuring compliance with regulatory and marketing requirements, manage product launch activities and ensure smooth and efficient integration between MDT, supply chain and external operational activities develop Lean Six Sigma culture, skills sets and tools to further enhance patient satisfaction and operational excellence within our supplier networks
KEY TASKS & RESPONSIBILITIES
Works closely with the project managers and development teams to optimize product cost
Defines industrialization phases of a project/product that will be realistic, achievable and challenging
Ensures the implementation and operation of robust production equipment and processes at external suppliers that will ensure the availability, reliability and quality supply of devices
Ensures that new process methods are compliant with Lean strategy and initiatives
Defines with Marketing and Regulatory the packaging and labeling requirements and translate them into final product specifications
Leads the development and validation of packaging and labeling materials
Supports GPL and MLT teams and interact with supply chain with for the preparation and launch of new devices
Supports medical device S&OP monthly process
Develops and maintains manufacturing capacity models required to supply commercial devices as defined in the long term forecast
Supports the implementation of CAPA as well as complaints investigations to ensure a continuous product improvement and a high product reliability with a decreasing level of complaints
Supports manufacturing process integration, efficiency improvements and product yield enhancement activities with suppliers
Develops and implement programs to assure process reliability to achieve high quality product.Executes continuous improvement projects, implementation of best practices to ensure quality and operational excellence of all processes related to all departments
Provides project coaching and mentoring to development project teams using Lean Six Sigma (LSS) methodology and tools |
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Doctorate (Electronics, Micro-Electronics or Mech)
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15 years + |
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French : Speak Fluently
English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Geneva |
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Ms/PhD, University degree in Electronics, Micro-Electronics or Mechatronics
Fluent English & French
Minimum 12 years experience with proven track records in industrialization and production of medical devices or automotive industry
Experience in Lean Six Sigma (Back Belt a real plus)
Knowledge of Medical devices cGMPs (ISO 134865, 21CFR820…)
Proficient in Microsoft project or other project management software as well as other office software.
Excellent organizational, leadership, decision-making, communication and management skills.
Action oriented and able to operate effectively under tight deadlines and high workload.
Perseverant and goal oriented to provide committed deliverables on time.
Able to work in multi-cultural environment and to support multiple projects simultaneously.
Passion, self-motivator and excellent professional attitude.
Excellent written, verbal and listening skills. |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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