Christian Dorn
Trainer, Coach at Regulatory Thinking®- Claim this Profile
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German Native or bilingual proficiency
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English Full professional proficiency
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French Limited working proficiency
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Spanish Full professional proficiency
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Bio
Experience
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Regulatory Thinking®
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Switzerland
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Business Consulting and Services
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1 - 100 Employee
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Trainer, Coach
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Aug 2020 - Present
The regulatory requirements of the healthcare market as a strategic opportunity by integrating them in the business model development – that is the essence of Regulatory Thinking®. Together with inter-disciplinary partners, who have come together as a consortium, we have developed this unique mindset. By conveying this mindset, we want to enable startups, industries, and academics to navigate the regulatory and business pathway of their medical innovations faster, more efficient and more sustainable. Show less
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Stiftung für Medizininnovationen
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Germany
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Research Services
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Program Manager
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Aug 2020 - Present
The Medical Innovations Foundation was established in 2014. In coordination with our subsidiary, the Medical Innovations Incubator GmbH, we support the transfer of innovation in the sector of medical life sciences (Pharma, Medical Devices, Diagnostics, Digital Health). We focus the business model development by the interconnected elaboration of the 4Cs: C1 – Commercialization | Plan revenue in the healthcare system (e.g. reimbursement by insurances) C2 – Certification | Approve product & company C3 – Clinical Studies | Prove evidence of the product C4 – Copyright | Use data / property rights strategically As a central element of our training concept, we use the legal regulation (e.g. Medicinal Products Act, Medical Device Regulation, In-Vitro-Diagnostic Regulation) and quality management system processes (e.g. GxP, ISO 13485), to train a “Regulatory Thinking®” from the very beginning. A good example for this training framework is: (1) Our "Regulatory Thinking®" concept (https://www.regulatorythinking.de) (2) Our free "4C Accelerator" (https://www.mi-incubator.com/de/4c_accelerator-tuebingen/) Show less
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Nadine Meisel Innovation Consulting
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Barcelona, Cataluña, Spanien
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Program Developer
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Dec 2018 - Jun 2020
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SEAT,SA
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Spain
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Motor Vehicle Manufacturing
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700 & Above Employee
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Launch Project Management - Production Planning, AUDI-A1 Car-Project
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Nov 2015 - Nov 2018
Department: Production planing (new product launches)• Manufacturability: Problem escalation responsible for mgmt. board committees and coordination of related R&D projects• Car product launch in SEAT facilities: manage production process development till SOP, coordination of all projects in related departments (press shop, body shop, assembly, paint shop, quality, logistics, etc.)• Production investment budget planning: Controlling of target deviation KPIs, benchmarking• Simultaneously engineering teams R&D: responsible and interlocutor of AUDI Show less
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Product Cost Strategist
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Jan 2015 - Nov 2015
Department: R&D (competitor analysis)• Implementation of potentials: Reporting responsible for mgmt. board committees• Strategy development with Volkswagen Group for competitor cars analysis• Project leader: Product cost optimization program of existing SEAT modelsT
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Karlsruhe Institute of Technology (KIT)
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Germany
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Higher Education
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700 & Above Employee
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PhD Research Assistant
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Sep 2012 - Jan 2015
Department: Production systems• Predictive Maintenance: Breakdown dependent spare part supply strategies, Development of a Total cost of ownership (TCO) standard • Project support: Performance indicators optimizations at client plants for Robust Supply Chain• Teaching: Exam corrections of the lecture Integrated Production Planning
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Master Thesis
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Jul 2014 - Dec 2014
Department: Production systemsTitle of thesis: Interdependence-based key performance indicator model - A quantitative company-independent framework for manufacturing flow lines
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Research Assistant
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Sep 2012 - Jan 2013
Department: Production systems• Predictive maintenance - breakdown dependent spare part supply strategies: Development TCO-standard• Robust Supply Chain: Performance indicators development and optimizations at client plants• Teaching: Exam corrections of the lecture Integrated Production Planning
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LEAN student association
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Karlsruhe und Umgebung, Deutschland
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Project Manager
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Oct 2010 - Oct 2014
Active member in Europe’s first student association with focus on Lean Management (existing since 2006, approx. 150 members): - Head of internal training program for a problem solving method incl. team lead of one-week projects at Ziehl-Abbegg SE and Robert Bosch Gmbh. - Consulting project leader at partner companies with focus on throughput time and flexibility with the help of Critical Chain Project Management, Shop floor Management, decentralized planning and a continuous improvement structure. Show less
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Bosch
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Germany
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Software Development
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700 & Above Employee
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Process Analyst Intern for Bosch Production System (BPS)
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Feb 2013 - Aug 2013
Department: Lean Logistics + Production • Lean Management Trainings: Development and facilitation to impart Lean principles and their supporting elements for implementation. • Project leader for a new layout manufacturing cell: time/ergonomic studies, workshops with operators, definition and implementation of process standard • Project leader to change internal transport systematic to KLT-boxes: Value stream mapping/ -design, workshops to define interfaces, rollout/stabilization of set process Show less
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Festool Engineering GmbH
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Germany
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Business Consulting and Services
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1 - 100 Employee
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Bachelor Thesis
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Aug 2011 - Jan 2012
Titel of thesis: Development of an approach to implement an enterprisewide expansion and sustainable establishment of a targetoriented approach to process improvement using coaching as part of cooperation between management and employees.• Development of a service product: training program for the above descriped approach on Toyota Kata skills• Project member: Prototypical implementation of the program at clients
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Process Analyst Intern
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Feb 2011 - Jul 2011
• Training development: target condition in systematical continuous improvement• Lean administration consulting project: value stream mapping for offer creation process• Project leader: implementing an internal CRM-System• Client training programs for structured iterative problem solving
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Technical Sales Intern
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Sep 2009 - Oct 2009
Department: Sales • Development of a technical data sheet for marine onboard aggregates • Mathematical modeling of engine data and illustrating in diagrams • Editing of product presentations (marine diesel engine) for the global sales and marketing Department: Sales • Development of a technical data sheet for marine onboard aggregates • Mathematical modeling of engine data and illustrating in diagrams • Editing of product presentations (marine diesel engine) for the global sales and marketing
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Education
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Karlsruhe Institute of Technology
Master of Science (M.Sc.), Business Engineering -
UPV/EHU
Master of Science (M.Sc.), Business Engineer -
Karlsruhe Institute of Technology
Bachelor of Science (B.Sc.), Business Engineer