Tuomo Heinonen Email & Phone Number

Ingelheim Am Rhein, Rhineland-Palatinate, De

Leading 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

Digital therapeutics (DTx) focusing on AI-powered birth coaching program based on the Nordic Method: Clinically validated perinatal journey on mobile phone.

Chicago, Us

Senior 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

Chicago, Us

QA 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)

Espoo, Uusimaa, Fi

As 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 lecture: Healthcare digitalization, University of Helsinki, Political sciences, 28.8.2018• Guest lecture: Safety and technology in healthcare, Ilembula Hospital, Tanzania, 27.11.2018

Chicago, 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)

Tampere, Fi

Researcher 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.

Tampere, Pirkanmaa, Fi

Advisor 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

Valencia, Es

First 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.

Oulu, Northern Finland, Fi

Oulu, Northern Finland, Fi

iSTOC 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

Tampere, 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

Tampere, Fi

System engineering position- Design controls & risk management- Master's thesis on risk management process

Tampere, West And Inner Finland, Fi

09/2010 - 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

Espoo, 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

Tarttila (Valkeakoski), Fi

Education record

Master Of Health Science (M.H.Sc.), Health Economics

Master Of Business Administration (M.B.A), International Business Management

Doctor Of Philosophy (Ph.D.), Administrative Sciences

Master Of Science (M.Sc.), Information Technology / Biomedical Engineering

Bachelor Of Science (B.Sc.), Information Technology

Visiting Phd Student, Innovation Studies

Ph.D. Studies, Manchester International Summer School On Emerging Technologies

Ph.D. Studies, Regenerative Medicine: Bench To Bedside And Back

Law Studies

High School, Mathematics, Physics, Chemistry, Programming

Basic Level Diploma, Music