Senior Usability Engineer

SHL Medical; Stockholms kommun; Hybrid; SEK 649,983 - 866,644; Full time

Benefits offered by this job

Flexible hours

Hybrid working policy

Opportunities for professional development

Job summary

SHL Medical is seeking a Senior Usability Engineer in Stockholm to provide usability expertise in developing innovative medical devices. Responsibilities include managing usability files, conducting user studies, and supporting iterative design processes.

Applicants should have over 5 years of experience in Usability Engineering and a degree in Human Factors Engineering. The role offers a flexible work schedule and a supportive work environment focused on innovation.

Qualifications

• 5+ years of professional experience in Human Factors Engineering / Usability Engineering.
• Strong knowledge of usability engineering principles and methodologies.
• Experience with QMS systems and medical device standards.

Responsibilities

• Develop and manage Usability Engineering Files and strategies for regulatory submissions.
• Plan and conduct formative evaluations and user capacity testing.
• Generate research findings for publications.

Skills

Usability Engineering

Human Factors Engineering

User Interaction

English fluency

Education

Degree in Human Factors Engineering or Usability Engineering

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. 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.

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 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.
• Generate research findings 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, and related activities within Usability Engineering/Human Factors, 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 such as 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.