About the company

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

A Senior Usability Engineer is responsible for providing usability expertise to projects and programs supporting the department’s user centered design approach. Usability engineering involves the testing of designs at various stages of the development process, with users or with usability experts. Through user studies and expert know-how, the Senior Usability Engineer applies knowledge of design, materials and regulations to provide input to various departments on product usability.

Main Responsibilities

• Develop and operate within standard operating procedures (SOPs) aligned with risk management and design control frameworks, ensuring compliance with ISO 14971, IEC 62366, and FDA guidance.
• Support in developing work instructions and templates to for usability engineering and user centered design activities under the established SOPs.
• Plan and execute design-related research programs, including proposing scientifically supported design specifications for medical devices and providing justifications for existing specifications.
• Generating research findings in relevant contexts for publications.
• 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.
• Define usability-related design inputs such as risk control measures (RCMs) or enhancements for user experience (non-risk-related design inputs).
• Plan and conduct formative evaluations (field work) to gather user feedback and support iterative design.
• Plan and conduct user capacity testing (field work), gather user feedback on tasks and on designs and support the iterative user-centered design.
• Create quick reference guides for usability evaluation purposes.

• Other tasks related to the position.

Minimum Requirements

• 5+ years of professional experience as a Human Factors Engineer / Usability Engineer in the medical devices space.
• Strong knowledge of work principles, 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.
• Experience in verification and validation of medical devices.
• Degree in Human Factors Engineering, Usability Engineering, or equivalent.
• Fluent in English, speech and writing.

Preferred Requirements

• Experience in combination products like autoinjectors, pen injectors, electric-mechanical autoinjectors, infusion systems, safety syringes/cartridges, etc
• Fluent in Swedish, speech and writing

We Offer

• A company culture Focusing on our Customers, Operating with Ethics and Integrity, Driving Simplicity, Learning, Improving & Delivering Together.
• Challenging assignments in a fast growing and innovative industry. 
• Various opportunities for personal and professional development within a global organization. 
• Flexible hours and hybrid working policy.   
• A modern working environment in Nacka Strand, Stockholm, with multicultural and motivated teams.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents.

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

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