Senior Usability Engineer (m/w/f)

LivaNova; München; Vor Ort; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Usability Engineer to ensure compliance with usability engineering processes in a dynamic medical device environment. In this role, you will lead usability validation studies, develop essential documentation, and collaborate with regulatory and quality teams to uphold high standards. This position offers a unique opportunity to influence product development while navigating complex regulatory landscapes. Join a supportive and inclusive team that values diversity and empowers you to drive meaningful change in healthcare innovation. If you're passionate about enhancing user experience in medical devices, this role is a perfect fit for you.

Leistungen

Supportive and inclusive environment

Professional career growth opportunities

Exposure to advanced medical device processes

Competitive base salary

Variable short-term & long-term incentives

Qualifikationen

• Several years of experience in usability engineering or regulatory documentation.
• Strong understanding of IEC 62366 and FDA human factors guidance.

Aufgaben

• Lead summative usability validation studies to meet regulatory requirements.
• Develop usability documentation and ensure compliance with FDA and IEC standards.

Kenntnisse

Usability Engineering

Regulatory Compliance

Technical Writing

Usability Risk Management

Analytical Skills

Organizational Skills

Ausbildung

Bachelor's or Master’s degree in Human Factors

Biomedical Engineering

Cognitive Psychology

Tools

Polarion

Jira

Jobbeschreibung

Join us today and make a difference in people's lives!

Senior Usability Engineer (m/f/d)

Position Summary:

The Senior Usability Engineer ensures that usability engineering processes comply with regulatory requirements and that all necessary documentation is completed for product approval. This role focuses on usability risk management, summative validation testing, and maintaining compliance with IEC 62366 and FDA expectations. The specialist will work closely with regulatory, quality, and R&D teams to ensure usability is properly documented and integrated into product development.

General Responsibilities

• Lead the planning, execution, and reporting of summative usability validation studies to meet regulatory requirements.
• Develop and maintain usability-related documentation, including usability engineering files (HFE File), usability risk assessments, specifications, plans, and validation reports.
• Work closely with the regulatory and quality teams to ensure usability documentation aligns with FDA and IEC 62366 requirements.
• Support the integration of usability risk management with overall product risk management.
• Track and manage usability findings and improvements.
• Ensure consistency in usability documentation across multiple projects and product releases.
• Provide usability training and guidance to other teams to improve documentation quality.
• Stay up to date with evolving regulatory requirements related to human factors and usability engineering.

Skills and Experience

• Bachelor's or master’s degree in human factors, usability engineering, regulatory science, biomedical engineering, cognitive psychology, or a related field.
• Several years of experience in usability engineering, human factors, or regulatory documentation in a medical device or highly regulated industry.
• Strong understanding of usability risk management and regulatory compliance (IEC 62366, FDA human factors guidance).
• Experience conducting and reporting summative usability validation studies.
• Proficiency in technical writing and creating structured usability documentation.
• Detail-oriented with strong organizational and analytical skills.
• Experience working with documentation management tools such as Polarion, Jira, or similar.

What we can offer you

In addition to providing you with a supportive, inclusive, and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

• A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth.
• Exposure to a state-of-the-art medical device development process, in close co-operation with international clinicians.
• Competitive base salary.
• Variable short-term & long-term incentives.

If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent, and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race, or any other legally protected classification.