Head of Usability and Industrial Design

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

We are seeking a dynamic and experienced Manager of Human Factors, Usability Engineering, and Industrial Design to lead a multidisciplinary team responsible for the user-centered design of cutting-edge autoinjector medical devices. The ideal candidate will have a strong background in human factors engineering (HFE), usability testing, and industrial design, coupled with proven leadership experience in a regulated medical device development environment. This role plays a pivotal part in ensuring that our devices are safe, effective, and intuitive for end-users, including patients, caregivers, and healthcare professionals.

Main responsibilities

Team Leadership & Development

• Lead, mentor, and develop a cross-functional team of human factors specialists, usability engineers, and industrial designers.
• Foster a collaborative, innovative, and inclusive team culture focused on continuous improvement and professional growth.
• Allocate resources effectively to support multiple projects and ensure timely project delivery.

Human Factors & Usability Engineering

• Oversee the planning, execution, and reporting of human factors engineering (HFE) activities to meet regulatory requirements (FDA, ISO 62366, IEC 60601).
• Define user needs and requirements, ensuring alignment with risk management activities (per ISO 14971) and Design History Files (DHF).
• Supervise formative and summative usability testing, including protocol development, participant recruitment, data analysis, and regulatory submissions.
• Oversee human factors risk analysis, including use error risk identification, task analysis, and mitigation strategies.

Industrial Design & User-Centered Development

• Supervise the creation of user-centered, intuitive, and aesthetically appealing designs for autoinjector products.
• Collaborate with mechanical and systems engineering teams to ensure ergonomic design principles are applied throughout the product lifecycle.
• Oversee prototyping, 3D modeling, and design validation activities, ensuring designs are aligned with user needs and commercial objectives.

Regulatory Compliance & Quality

• Ensure all HFE and usability activities comply with FDA, MDR (EU Medical Device Regulation), and other global regulatory standards.
• Author and review HFE/Usability Engineering documentation for regulatory submissions (e.g., HF/UE Reports for FDA).
• Support internal and external audits related to human factors, usability, and design controls.

Project Management & Stakeholder Collaboration

• Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Clinical teams, to ensure alignment with project goals.
• Represent the HFE, usability, and industrial design team in design reviews and executive-level meetings.

Minimum Requirements

• Bachelor’s or Master’s degree in Human Factors Engineering, Usability Engineering, Industrial Design, Cognitive Psychology, Biomedical Engineering, or a related field.
• Minimum 7+ years of experience in human factors, usability, and/or industrial design, with at least 3+ years in a management or leadership role.
• Strong knowledge of human factors regulatory guidelines, including FDA Guidance on Human Factors for Medical Devices, IEC 62366, and ISO 14971.
• Strong leadership, decision-making, and team development skills, with experience managing cross-functional teams.
• Expertise in usability testing, task analysis, root cause analysis, and risk assessment.
• Experience leading or supporting regulatory submissions to the FDA, EMA, or other health authorities.

Preferred Requirements

• Proficiency with tools for 3D design (e.g., SolidWorks, Creo) and user testing.
• Experience with autoinjector design, parenteral drug delivery, or other drug-device combination products.
• Familiarity with design thinking, Lean UX, or Agile methodologies in the development of medical devices.
• Excellent communication, presentation, and collaboration skills to engage with internal teams, external partners, and regulatory agencies.
• Fluency in English

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 including your CV, motivation letter, and all other relevant documents 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.