ID1082
Human Factors and Usability Engineering
B.S. Information Science, Cornell University, Ithaca, New York, USA
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Human Factors and Usability Engineering (HFE/UE) for US FDA and EU MDR medical device and combination products
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End-to-end HFE/UE expertise, including documentation and conduct of early-stage ideation and research, through validation/summative evaluations
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Formative and summative usability studies: Planning, Moderating, Analysis, and Reporting
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Use-related risk analysis and heuristics evaluations
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Development of HFE/UE reports and Usability Engineering files
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Post-market surveillance and UOUP
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Project and people lead
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Project scoping and budgeting
Key results
- Cat. I-III Medical Devices: Biological Evaluation Plans and Biological Evaluation Reports, MDD-MDR transition, and documentation maintenance according to standards and regulations
- Toxicological risk assessment and biosafety of worst case contacting medical devices (implants with long term/permanent contact and externally communicating devices with contact to circulating blood)
- Biological Evaluation of materials and tools used in the manufacture of medical device
- >20 scientific publications and review articles in peer- reviewed journals from 7 years in academic positions (Google Scholar: 843 citations, H-index 11)
- Multiple reviewer assignments for journals such as International Journal of Toxicology, Laboratory Animals, and Comparative Medicine
Software/Standards
Extensive knowledge in:
- FDA HF Guidance: Applying Human Factors and Usability Engineering to Medical Devices; Content of Human Factors Information in Medical Device Marketing Submissions; Application of Human Factors Engineering Principles for Combination Products
- IEC 62366-1:2015+AMD1:2020 and IEC TR 62366-2:2016 (Usability Engineering)
- ISO 14971 (Risk Management)
- ANSI/AAMI HE75:2009 (HFE – Design of Medical Devices)
General knowledge in:
- ISO 13485:2016 (Medical Devices – Quality Management)
- IEC 60601-1-11:2015 (Medical Electrical Equipment)
Personal Characteristics
Detail-oriented, enthusiastic, and highly-competent Human Factors project manager with 7+ years as a Human Factors Engineering consultant for medical devices and combination products. Experienced working with cross-functional and international teams, including clients based in North and South America, Europe, Asia, and the Middle East.
Conducts HFE activities with empathy for the intended users centralized in his approach. Expert at tailoring usability study session moderation style to individual participants, resulting in deep insights into root cause analysis and product improvements.
In his free time, find him in the mountains, hiking, snowboarding, and enjoying the view.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com