Usability Engineering Expert
We are seeking a seasoned Usability Engineering Expert to join our global team. As a key member, you will be responsible for expanding your clinical and technological expertise in a high-impact role.
This position can be based in either our HQ or R&D Site, with talented colleagues on both sites working towards improving patient care.
You'll lead a dedicated team of experts in Design Validation and Usability, working towards saving lives through innovative solutions.
Key responsibilities include:
* Apply usability engineering principles throughout the product lifecycle according to IEC 62366-1 standards
* Perform design validation to ensure compliance with MDR, ISO 13485:2016 regulations and FDA 21 CFR guidance
* Serve as primary contact for usability and design validation inquiries and decisions within assigned projects
* Contribute to defining user needs to ensure they are validatable
* Lead use-error risk analysis activities and support the risk management process by contributing to Product Risk Evaluation with knowledge of use errors and clinical use
* Plan and execute formative evaluations, design validation, and summative usability studies with intended users
* Identify simulation manikins suitable for product evaluation
* Author and contribute to usability engineering files, design validation, and documentation for regulatory submissions
Success requires proactive drive, commitment, and responsibility for tasks. You're thorough, quality-minded, and have excellent interpersonal skills and situational awareness.
Requirements include:
* 5+ years of experience in usability engineering for medical devices with a solid understanding of design control
* Experience working with identifying and defining use-introduced risks and product requirements
* Technical interest with a patient-centric mindset
* Interest in anatomy and physiology, and clinical knowledge is an advantage
* Strong communication skills and knowledge about its impact in both communication with users and colleagues
As a global company, fluent English communication is essential. Only applications received in English will be considered.
Why this role matters: Our goal is to improve patient care and save lives through innovative solutions. We prioritize knowledge sharing and exploitation of best practices.
What we offer: A collaborative and dynamic work environment with opportunities for growth and development.
How to apply: Please submit your application in English, including your resume and cover letter.