Usability Engineer

About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Usability Engineer is responsible for providing usability expertise to projects. They will conduct testing of designs at various stages of the development process, with users or with usability experts. Through user studies, the Usability Engineer will apply knowledge of design, materials and regulations to provide input to various departments on product usability. Ultimately, the Usability Engineer is essential in ensuring SHL’s products meet the needs of our various patients, enabling them to live a more independent life.

Main Responsibilities

• Establish and manage SOP in accordance with risk management and design control requirements which comply with ISO 14971, IEC 62366, and FDA Guidance.
• Plan and execute design-related research programs, including proposing scientifically supported design specifications for medical devices and providing justifications for existing specifications.
• Develop custom research tools, such as a tool for evaluating autoinjector holding stability during prolonged injection time, and another tool for measuring user strength in manipulating autoinjectors.
• Develop and manage Usability Engineering Files, including Use Specification, Usability Engineering Plan, User Interface Evaluation Plan, Formative and Summative Evaluation Protocols/Reports, and Usability Engineering Report.
• Design Usability Engineering strategies for regulatory submissions, including implementing the complete process or pursuing a waiver for validation testing.

Minimum Qualifications

• 3-5 years of Usability Engineering experience in medical device product development
• Strong knowledge of work principles and methodologies as well as related activities within Usability Engineering/Human Factors, and User Interaction and Experience
• Experience with QMS systems as well as standards and regulations related to the medical device field
• Fluent in both Swedish and English, speech and writing
• Engineering or Industrial Design degree, or equivalent work experience

Preferred Qualifications

• Experience in combination products like autoinjectors, pen injectors, electric mechanical autoinjectors, infusion systems, safety syringes/cartridges etc.
• Experience with verification and validation

We Offer:

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy. 

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.