Senior Usability Engineer

SHL Group; Stockholms kommun; Hybrid; SEK 563,910 - 751,880; Full time

Benefits offered by this job

Flexible hours

Opportunities for personal and professional development

Modern working environment in Nacka Strand

Job summary

SHL Group is seeking a Senior Usability Engineer in Stockholm to provide usability expertise for user-centered design in medical devices. The role requires strong knowledge of usability engineering principles and substantial experience in the field. You will work on various tasks, including developing usability strategies, managing engineering files, and conducting formative evaluations.

The ideal candidate has over 5 years of experience, a relevant degree, and fluency in English, with Swedish as a preferred language. SHL Group offers a flexible working environment and opportunities for professional development.

Qualifications

• 5+ years of professional experience as a Human Factors Engineer / Usability Engineer in the medical devices space.
• Strong knowledge of Usability Engineering/Human Factors principles and methodologies.
• Experience with QMS systems and medical device regulations.

Responsibilities

• Develop and operate within standard operating procedures aligned with risk management.
• Plan and conduct user capacity testing to gather feedback.
• Generate research findings for publications and manage Usability Engineering Files.

Skills

Usability Engineering

Human Factors Engineering

User Interaction

Verification and Validation of Medical Devices

QMS Systems

Education

Degree in Human Factors Engineering, Usability Engineering, or equivalent

Job description

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.

Qualifications

• 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

• 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.