Tuomo Heinonen Email and Phone Number
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Internationally minded and cross-functionally oriented leader experienced across private, public and third sector, and academia:- Private healthcare sector experience in pharmaceutical and medical technology industries, working in start-ups, established companies, and international top 20 corporations globally by revenue in respective industry. - Public sector experience in competent authority led network working group.- Third sector experience in several NGO's and registered association's boards as chair or member, and international development co-operation projects. - Academic experience in publishing in international scientific journals, funding applications, conducting lifecycle of research projects, and presenting research outcomes for large crowds also in more popularized manner. Continuously learning contributing to higher performance. Formal educational background includes engineering studies in software engineering (B.Sc. tech.) and medical informatics (M.Sc. tech.), health economics (M.H.S.), international business management (M.B.A), and commercialization & innovation (Ph.D.). In addition, courses in law, pharmacology, biotechnology business, regenerative medicine, and Asian business. Informally learning healthcare systems, medical technologies, digital transformation, different company functions, among other topics.Some of my characteristics:- Skilled in debating. In international business environment received feedback on open and constructive debate. Debate team captain winning JCI national debate and represented Finland in European contest. - Pragmatic. Receiving feedback on having a proactive and hands-on approach with an attitude to understand the problem and being solution-oriented.- Fast learner. Receiving feedback such as "really impressed how well up to speed you are after only a short time in the company" and "clearly you are a fast learner & by sharing your expertise so openly you bring us as a team & a company forward".
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Head Of Regulatory AffairsBoehringer Ingelheim Mar 2023 - PresentIngelheim Am Rhein, Rhineland-Palatinate, DeLeading local Regulatory Affairs function and team in Finland.► Products: Coordination and management of local translations with centrally approved and mutually recognised products (CAP/MRP), local coordination of new marketing authorizations, marketing authorization withdrawals and market notifications► Finance: Responsible for annual budget planning and management of local Regulatory Affairs function, purchase orders, invoice approvals► Marketing: Member in brand team for lung product► Patient Centricity: Patient and customer advocate, co-authoring article on digital patient pathways, collaborating on electronic patient information
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Vice Chair In Working Group: Medicine User Involvement Ensures The Success Of Medicinal TreatmentNational Medicines Information Network Sep 2024 - Present
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Member Of The Steering GroupNatal Mind Jun 2023 - Dec 2024Digital therapeutics (DTx) focusing on AI-powered birth coaching program based on the Nordic Method: Clinically validated perinatal journey on mobile phone. -
Staff Technical Project ManagerGe Healthcare Oct 2022 - Feb 2023Chicago, UsSenior role responsible for global IB engineering activities for High Acute Care business product lines: CHA Anesthesia, CHA Critical Care, Centricity Critical Care.► Driving IB engineering activities, daily management and prioritization► Defining execution plan of projects and leading the execution based on the scope, quality requirements, expected timeline and available resources► Scrum Master and team lead in IB engineering team► Managing execution of NCs/Investigations/CAPAs to meet due dates and working with cross-functional teams in defining, executing and completing defined actions► Managing End-of-Life programs to support IB conversion -
Quality Lead EngineerGe Healthcare Jan 2019 - Sep 2022Chicago, UsQA leadership within cross-functional product development core teams with multiple NPI programs and several maintenance projects for current IB as well as supporting production and design transfers in both receiving and pitching site.► Focus on continuous multi-parameter patient monitoring and parameters (hemodynamic, respiratory, neurophysiological)► Proven ability to work effectively globally within a matrix environment with cross-functional teams► Product development: Guiding, reviewing and approving design inputs, design outputs, risk management, verification, validation, design transfer, usability, software development life-cycle, DHF, DMR, DHR► Product quality: Driving improvements in e.g. complaint rate, DPU, IFR30/90/365, warranty costs► Problem solving: Collaborating with cross-functional teams in solving complex product, compliance and process related problems and challenges► LEAN: Proficient in DMS, 5S, standard work, 3P, VSM, visual management, hoshin kanri, problem solving, speed design review, etc.► Lead auditor (approx. 3-4 internal audits / year)Trainings:Technical problem solving (3 days)Reliability engineering (3 days)Introduction to clinical world (2 days)Clinical parameters (0,5 days)
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ConsultantClinipower Finland Ltd Jan 2018 - Dec 2018Espoo, Uusimaa, FiAs a consultant in boutique consulting firm I led multiple projects and supported sales and marketing.Selected projects:- Managed a strategic business critical change program with an aim to establish a new medical device manufacturer department within client firm doing international business. In addition to required processes and functions I successfully led a regulatory go to market strategy development and operationalization for a specific medical device.- Day-to-day quality engineering support for a global medical device manufacturer in bringing new products to the market- Project manager for quality management system (QMS) development project resulting a certified ISO13485 QMS- For several organizations developed a gap-analysis by auditing and analyzing a (potential) medical device manufacturer against medical device regulation requirements- A regulatory strategy development for a university spin-off candidateLecturing:- From innovation to commercial product in healthcare (3h lectures): Saranen Consulting, 24.5.2018- Risk management in healthcare (6h lectures): Saranen Consulting, 20.7.2018 -
Guest LecturerFreelance Aug 2018 - Nov 2018• Guest lecture: Healthcare digitalization, University of Helsinki, Political sciences, 28.8.2018• Guest lecture: Safety and technology in healthcare, Ilembula Hospital, Tanzania, 27.11.2018
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Quality Assurance Lead EngineerGe Healthcare Oct 2016 - Jan 2018Chicago, Us► QA leadership in cross-functional teams: New Product Introduction (NPI) core team (project size of 150 engineers) and several installed base (IB) change and maintenance projects► As a QA lead collaborated closely with product management, manufacturing, supply chain, service, engineering, medical affairs, regulatory assurance and supplier quality contributing to a good overall understanding of processes and global operations.► Active international collaboration with R&D locations in India, US, China and Finland► Successful experience in operating and leading under a matrix organization► New Product Introduction (NPI) and installed base (IB) change and maintenance projects► Computerized system validations (CSV)► Test automation development from QA viewpoint► Internal and external audits (e.g. NB audits, MDSAP)► Design controls (including DHF, DMR, TF)
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Researcher & Ph.D. StudentUniversity Of Tampere, School Of Management Jan 2013 - Dec 2016Tampere, FiResearcher in Urban and Regional Studies Group SENTE doing PhD about regenerative medicine innovation ecosystem and commercialization of regenerative medicine innovations. The research is in the intersection of economic geography and innovation studies.My activities on PhD thesis can be divided into three phases:- Phase I (1/2013 - 12/2013): Part-time PhD student (mostly evenings and weekends)- Phase II (1/2014 - 12/2015): Full-time project researcher- Phase III (1/2016 - 10/2016): Full-time PhD student (funded by School of Management)- Public defense of dissertation on December 2, 2016.► International collaborations and participation including: 2 research visits (3 months & 2 weeks) in Valencia, Spain, resulting a journal article and a book chapter; participation and presentation in international conferences (Spain x2, Norway, Italy, Sweden); 2 summer/winter school (UK, Netherlands)► Altogether publications included: 3 peer-reviewed international journal articles, 1 peer-reviewed book chapter, 2 non-peer-reviewed articles, co-editor in report in which co-authoring 2 chapters.► Conducted 24 interviews in academia, government, hospital, business, and development organizations► PhD dissertationPost-doctoral research included:- Kolehmainen, J., Ruokonen H. & Heinonen, T. (2019). Tulevaisuuden kehittämisyhtiö rajanylittäjänä. Focus Localis 3/2019.- Ortega-Colomer, F.J., Pekkola, E. & Heinonen, T. (2018). Role of engineering education in transition of industry: Central steering or local resilience? In: Pinto, H. and Baycan, T. (Eds.). Resilience, crisis and innovation dynamics. Edward Elgar. -
Advisor, Technology CommercializationBiomeditech - Institute Of Biosciences And Medical Technology Jan 2016 - Aug 2016Tampere, Pirkanmaa, FiAdvisor in consideration of different business models, stakeholder and resource analysis, financial forecasting and financial model development, and product strategy for following applications:- Microfluidic in vitro system for dynamic tissue and cell studies- In vitro model for myelination -
Visiting ResearcherIngenio (Csic-Upv) 2015 - 2015Valencia, EsFirst research visit (3 months) on March - May, 2015:• Presentation in Cluster workshop (28. - 29.5.2015)• Presentation about PhD thesis in internal seminar (7.5.2015)• Received feedback to develop further the dissertation manuscript and to focus on some key areas• Collaborated a journal articleSecond research visit (2 weeks) on December, 2015. - Collaboration with a book chapter. -
Advisor, Quality And RegulationIstoc Jan 2014 - Sep 2014Oulu, Northern Finland, Fi -
Quality ManagerIstoc Apr 2013 - Dec 2013Oulu, Northern Finland, FiiSTOC Oy was founded on February 1st, 2012. iSTOC has developed a point of care diagnostic service for remote patient testing and online coaching by exploiting mobile device technology and cloud services.• Member of executive management team• Managed quality management system development project (ISO 9001 / ISO 13485) and related standards (ISO 14971, IEC 62304)• Coordinated product regulation in EU and U.S.• Conducted CE mark for product according to IVDD
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Development SpecialistMylab Oy Jan 2012 - Apr 2013Tampere, Fi• ISO 9001 / ISO 13485 Quality management system development• Software engineering process implementation and development according to IEC 62304• Risk management process implementation and development according to ISO 14971• Internal auditing• Software development coordination (interim project manager)• Project manager responsible for project plan building for bidding purposesOutcomes:► Transformation of old organization culture towards process-orientation and coached company staff in risk and quality management► Establishment of risk management process and software development life-cycle processes and assisted in overall quality management system establishment► In New Product Introduction project documented user and functional requirements, coordinated risk analysis, conducted system level product testing, introduced improvement opportunities► Deployment of processes and tools to subcontractor’s site according to company’s policies -
System DesignerMylab Oy Feb 2011 - Dec 2011Tampere, FiSystem engineering position- Design controls & risk management- Master's thesis on risk management process
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Research Assistant / It System SupportTampere University Of Technology Apr 2007 - Dec 2010Tampere, West And Inner Finland, Fi09/2010 - 12/2010 Research Assistant, Department of Automation Science and Engineering06/2010 - 08/2010 IT System Support, Faculty of Automation, Mechanical and Materials Engineering04/2007 - 05/2010 Research Assistant, Department of Automation Science and Engineering• Deployed state of art technologies and procedures• IT service desk • IT infrastructure management (including Windows Server 2003/2008, Active Directory, Exchange Server, Intranet, Computer classroom)• Automation science specific software administration• Testing and adoption of new technologies• Research about how to use ICT in education -
TraineeNokia Sep 2004 - Aug 2006Espoo, Southern Finland, Fi• Software development and prototypes• Languages: Symbian C++, Java• Platforms: Series 80 (Nokia 9300), Series 90 (Nokia 7710), Series 60Outcomes:► Great learning experience in R&D function collaborating across the Finnish sites (Toijala, Tampere, Helsinki)► Delivered solutions to internal customers in R&D organization -
System And Network AdministratorPäivölän Opisto Jun 2005 - May 2006Tarttila (Valkeakoski), Fi
Tuomo Heinonen Skills
Tuomo Heinonen Education Details
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Harvard Medical School Corporate Learning -
University Of Eastern FinlandHealth Economics
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Tampere University Of Applied SciencesInternational Business Management
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University Of Tampere 1925-2018Administrative Sciences
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Tampere University Of Technology 1965-2018Information Technology / Biomedical Engineering
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Tampere University Of Technology 1965-2018Information Technology
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Universitat Politècnica De València (Upv)Innovation Studies
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Alliance Manchester Business SchoolManchester International Summer School On Emerging Technologies
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Utrecht UniversityRegenerative Medicine: Bench To Bedside And Back
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University Of HelsinkiLaw Studies
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Päivölä School Of MathematicsProgramming
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Valkeakoski Music SchoolMusic
Frequently Asked Questions about Tuomo Heinonen
What company does Tuomo Heinonen work for?
Tuomo Heinonen works for Boehringer Ingelheim
What is Tuomo Heinonen's role at the current company?
Tuomo Heinonen's current role is Head of Regulatory Affairs @ Boehringer Ingelheim | PhD, MBA.
What is Tuomo Heinonen's email address?
Tuomo Heinonen's email address is tu****@****onen.eu
What schools did Tuomo Heinonen attend?
Tuomo Heinonen attended Harvard Medical School Corporate Learning, University Of Eastern Finland, Tampere University Of Applied Sciences, University Of Tampere 1925-2018, Tampere University Of Technology 1965-2018, Tampere University Of Technology 1965-2018, Universitat Politècnica De València (Upv), Alliance Manchester Business School, Utrecht University, University Of Helsinki, Päivölä School Of Mathematics, Valkeakoski Music School.
What are some of Tuomo Heinonen's interests?
Tuomo Heinonen has interest in Innovation, Management, Research, Technology, Science.
What skills is Tuomo Heinonen known for?
Tuomo Heinonen has skills like Software Development, Software Project Management, Risk Management, Software Engineering, Iso 13485, Project Management, Iso 14971, Iec 62304, Team Leadership, Iso 9001, R&d, Research And Development.
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