Job opportunity
Human Factors Specialist
- Are you excited about Human Factors/Usability Engineering and developing the medical devices of the future?
- Do you have a passion for user needs and assuring patient safety throughout the development processes?
- Are you skilled and experienced in planning, executing and documenting Usability activities in all phases of the development?
- Do you want to join our top motivated team of Human Factors Specialists, who work with dedication in cooperation with our clients to get new medical devices approved by the authorities?
- Do you thrive in a consulting role in a fast-paced environment?
Then join Technolution and become part of an innovative, rapidly growing company, where you will boost your professional experience and knowledge, while assisting and advising our clients in developing the medical devices, combination products and IVD products of the future.
Job description
In the job as Human Factors Specialist, you will join our team of highly skilled experts in Usability/Human Factors Engineering. You will be driving Usability activities externally in cooperation with our clients, while having the opportunity for professional sparring with your Technolution colleagues.
Your primary workplace will be in the Copenhagen area, and you should expect a limited amount of traveling in connection with test activities, primarily in Denmark and USA.
You will participate in
- Planning and executing Usability activities in compliance with current regulatory standards for medical device development, such as IEC 62366-1, ISO 14971 and FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices”
- Preparing, executing, analyzing and reporting Usability evaluations
- Formative Usability tests of user interfaces
- Summative Usability tests (Human Factors validation tests.)
- Identification and analysis of use errors and use-related risks
- Specification of user interface design requirements
- Continuous improvement and optimization of our Usability procedures and templates in collaboration with the Technolution team.
Your profile
You have minimum 2 years’ experience with Human Factors/Usability Engineering within medical device development. You are outgoing, open minded, a great communicator, well structured, analytical and proactive. The role as Human Factors Specialist requires that you are systematic and able to work efficiently alone and in groups.
Some of your qualifications:
- Good understanding of and experience with IEC 62366-1:2015 and FDA’s 2016 Guidance “Applying Human Factors and Usability Engineering to Medical Devices.”
- Hands-on Usability test experience including the creation of test protocols, moderator guides, Usability reports and documentation
- You are fluent and precise in Danish and English, both written and spoken
- Relevant education on bachelor or master’s level or relevant training
- Knowledge of and experience with Design Control and ISO 14971:2019 is an advantage, but not a requirement
- As a person, you see opportunities, have great social skills and a structured approach to your work, take responsibility and meet deadlines.
What you can expect from us
When working at Technolution, you will have extensive contact with elite Danish MedTech companies, across industry segments and disciplines, and you will be a part of a company where professionalism and unity are keywords and where initiatives are welcomed and appreciated. We have regular events of both professional and social character and strive to create a safe, trusting and developing culture. We take pride in our unpretentious and professional company environment where we know each other well and are good at making room for each other. We are always open to be inspired by your contribution and you will have plenty of opportunities to contribute to the continuous improvement of Technolution. We offer attractive working conditions both practically, professionally, socially and economically.
We look forward to hearing from you
Please send your application and CV to job@technolution.dk. If you have questions or want to know more, please reach out to Jon Storm Madsen, Head of Usability Engineering, tel. (+45) 6130 7243.
Applications will be handled continually (all applications will be stored for 6 months and then deleted).
