Experience
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Technical Expert – Human Factors Engineer
at Novartis
March 2019 - at Present
Kanton Basel-Stadt
lanning of Summative study. Late stage development of combination product drug delivery devices. Benchmark study of prefilled insuling devices.Development of Instructions For Use. Preparing of filing documentation. Preparation of study material for formative study.
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Human Factors Engineer
at F. Hoffmann-La Roche
April 2017 - February 2019
Kanton Basel-Stadt
Late stage development of combination products. Planning of Summative study for autoinjector for Rheutoid Arthritis. Preparing training material before launch. Training affiliates in device use before launch. Early phase development of child resistant packaging for tablets. Development of Quick Reference Guide. Preparing of formative study. Close collaboration with Device Team, QA and Regulatory. Close collaboration with external vendors. Preparing filing dossier FDA.
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Device Development and Human Factors Engineer
at Novo Nordisk
March 2007 - July 2016
Region Hovedstaden
Device Development and Human Factors Engineer Human Factors Engineering for prefilled medical devices. Gather needs from the projects stakeholders, planning user boards, usability tests and feed the input from studies back to the project team and finding the most optimal solution or compromise. Responsible for planning, supervising and documenting formative user studies and usability tests for next generation prefilled insulin devices. Designing an App to be used in future user studies. Coordinating a large number of stakeholders, external consultants, design agencies, tool shops and manufacturers in order to develop prototypes for user evaluation. Facilitator of several creative workshops to solve technical problems across teams for nearly 10 years. Part of a team that designed creative meeting rooms, very popular for workshops.
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Primary packing development
at Novo Nordisk
April 2002 - February 2007
Region Hovedstaden
Responsible for optimizing launched tablet dispensers and insulin cartridge components with regards to customer satisfaction, intuitiveness and increased yield in large scale production. Updating registration files for primary containers in close contact with Regulatory and QA. Coordinating change requests between stakeholders. Optimizing and test of tablet dispenser at the injection moulder. Updating of Autocad drawings.
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Packaging Designer
at Superfos Packaging
February 2000 - March 2002
Region Sjælland
Responsible for designing packagings for food and non-food with tamper evident openings. Analysing injection moulded packagings with Tamper Evident openings. Designing a range of openings to test in production and with customers. Presenting the company at Packaging Fairs with a demonstration of the 3D design programme: Solid Designer. 3 months pre-sales assignment at the affiliate in Maryland, US, to clarify user needs. Graphical decoration of the company’s Easter and anniversary packagings.
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Packaging Developer
at MD Foods (Arla Foods)
February 1995 - February 2000
Region Midtjylland
Designing packaging for 3 butter- and 4 mould cheese dairies. Updating existing packagings, line extensions and new country variants. Coordinate a large number of stakeholders; 7 dairy chiefs, dairy store-managers, employees at the filling and packaging lines, external graphic designers, marketing, label printers, cardboard producers, film- and foil suppliers. Update “Lurpak” butter design in collaboration with the Brand Manager and designers. Approving product quality at print start. Machine test of foil, labels and boxes on packaging lines. Transportation test of product packed on pallets. Designing a new development manual for R&D. Design and construction of an impressive star for the Christmas tree at the reception, made out of foil from all the blue cheese variants.
Education
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Advanced Human Factors for Medical Devices
at AAMI
2016 - 2016 (1 year)
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Human Factors for Medical Devices
at AAMI
2014 - 2014 (1 year) Georgia
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Creative Problem solving Institute
at CPSI
2013 - 2013 (1 year)
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Power2Influence
at power2influence
2012 - 2012 (1 year) Region Sjælland
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Creative Problem solving Institute
at CPSI
2008 - 2008 (1 year)
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Creative Facilitations
at Krea Leder
2008 - 2008 (1 year) Region Hovedstaden
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Bachelor of Science in Engineering, BSc Eng., Plastics & Industrial Design
at Helsingør Teknikum
1989 - 1994 (5 years) Region Hovedstaden
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High School, math/music
at Holte Gymnasium
1985 - 1988 (3 years) Region Hovedstaden
Knowledge and keywords
Languages
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German Conversation
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Danish Native
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English Negotiation
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Swedish Conversation
Links
- https://www.linkedin.com/in/helene-juhldal-knopper-a0a855/
Hives
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Engineers and Technicians
379678 members