Senior Usability Specialist

Are you motivated working with Usability Engineering, and do you want to make a difference for our users in exiting innovative R&D projects? 
Then join Coloplast to become part of one of the best performing MedTech companies in the world.

As a Usability Specialist you will work in a social and highly skilled team with Industrial Designers, Prototype Specialist, Color-Material-Finish experts and 4 other Usability Specialists. 
You will be responsible for planning and executing the usability engineering process in new product development for new medical devices. This individual will work closely with research and development, design, product management and regulatory teams to ensure that the usability of our medical devices properly address patient safety and needs, product performance, regulatory requirements, and commercial needs. The Usability Specialist is the main responsible for formative and summative tests/evaluations, and documentation in compliance with regulatory standards. The function will also conduct product usability requirements, identifying usability risks, creating use task analysis and user interface concepts, and improving overall user experience. The Usability Specialist will serve as a usability project lead on assigned project teams, as well as an internal ad-hoc consultant for matters related to usability throughout the company.

Duties and responsibilities:

• Apply usability/human factor engineering processes throughout product development (e.g. ISO/IEC 62366, US FDA HF guidance, ANSI/AAMI HE75, ISO 14971)
• Will be the usability project lead on assigned project teams 
• Collaborate with Design, System Engineering, Mechanical Engineering, Scientific Managers, User Researchers and Product Development teams to develop products that make life easier the users.
• Design, coordinate, and conduct early and late formative and summative usability tests, analyze and perform report on data, and present results and findings 
• Facilitate and complete use error analyses
• Author and contribute to documentation needed for creating Usability Engineering File and documentation for regulatory submissions
• Contribute to task analyses, cognitive walk-throughs, and other formative design and evaluation methods
• Assist in training colleagues in usability processes and methods
• Bring the users close in during the development process 
• Commission, coordinate and ensure execution of usability activities with external vendors
• Provide empirically based recommendations based on usability standards, data, and best practices
• Take part in relevant audits 

Education and experience:
You have a Master's degree in Engineering, Biomedical Engineering, Human Factors Engineering, Ergonomics, Usability Engineering, Industrial Design, Interaction Design, Design & Innovation, Engineering Psychology or other relevant disciplines.

Furthermore, you have:

• Good understanding ISO 14971 (Risk Management) requirements, FDA Guidance, and IEC 62366 
• Hands-on usability testing experience including the creation of protocols, moderator scripts, and usability reports
• Experience with planning and moderating usability testing
• Excellent written and oral communication skills
• Maybe you have experience working with/ liaising with external research consultants
• Demonstrated capability with requirement management, data acquisition, and analysis 
• Strong interpersonal skills and the ability to work collaboratively on a cross-functional team
• Personal and professional capability to research within the area of intimate health care product 
• Strong organizational and planning skills
• Self-motivated and self-managed with a high degree of analytical ability
• Fun and professional to work with

Interested?
One position of Senior Usability Specialist is available.
We prefer a Senior Usability Specialist, but prioritize to find the right candidate. Therefore, seniority level will be determined based on the candidate’s level.
If you have questions or want to know more about the position, please contact Hans Falleboe, Head of Design and Usability Engineering at +45 49113283 or Stine Renberg, Senior Usability Specialist at +45 49113320.

Deadline:
Please submit your application no later than 31st of September, 2023. Please notice, that we take candidates into the recruitment process continuously and close the position, once we have found the right candidates.
 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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