Human Factors Engineering Specialist
MSc. Design and Innovation
Available for: Part-time
Competences
Medical Device Product Development & Design Controls:
- Development of HFE/Usability strategies.
- Implementation and integration of HFE/Usability discipline in projects and organizations.
- Development of processes, work tools and templates to improve HFE/Usability execution and integration with Risk Management and general product development and Design Control activities.
- Design, planning, execution and reporting of Formative and Summative Evaluations.
- Use-Related Risk Analyses, e.g. Task Analysis.
- Authoring and improvement of HFE/Usability SOPs and Work Instructions.
- HFE/Usability educational training (for organizations as well as HFE practitioners). Sparring and mentoring.
- Requirements Management / Requirements Engineering.
General Design & Product Development:
- User-Centric Design & User Interface conceptualization.
- Design Research & User Testing.
- Facilitation and graphic facilitation of workshops, strategy sessions, co-creation session, etc.
Key results
Establishment of Usability/HFE in organization
Build-up of HFE/Usability function, team, processes and facilities for international medical device manufacturer
(LivaNova, DE/IT/US, 2018-2020)
Full HFE/UX responsibility on flagship MD project
Development of strategy (UI design completion, Usability/HFE analyses, evaluation/testing and documentation) and HFE execution for complex, highly safety-critical medical device UI.
Management of internal and external collaborators.
(LivaNova, DE, 2018-2020)
2015-2017:
Member of Design Control and Usability/UX Expert Teams
Cross-functional and -organizational working group improving and integrating development and documentation processes and tools.
(Radiometer, DK)
Elected speaker at HFES International Health Care Symposium
HFE/Usability strategic planning methods and tools for implantable medical devices
(Boston, 2018)
Software/Standards
- Microsoft Office
- Siemens Polarion/PTC Integrity (ALM tools)
- InVision
Extensive knowledge in:
- ISO 13485, 21 CFR 820(QSR, Design Controls).
- IEC 62366-1, IEC 62366-2 (Usability)
- ISO 14971 (Risk Management).
- FDA Guidance:
Applying Human Factors and Usability Engineering to Medical Devices.
Personal Characteristics
Is driven by a constant desire to improve and innovate – and excels at finding creative solutions in medical device design as well as for strategies, processes, documentation and ways of working.
Her technical understanding combined with excellent interpersonal skills and curiosity makes her a great ambassador for any manufacturer when interacting with health care professionals or patients to understand their challenges, preferences and needs.
She sees her concise and enlightening communication of insights to business and product development stakeholders as her key contribution to optimal navigation between use safety, user needs and experience, technological possibilities, business opportunity and regulatory constraints.
She loves to contribute to creating a motivating and social and fun work environment.
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