Senior Usability Engineer (m/w/f)

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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.

• Experience in cardiopulmonary medical device development is a plus
• Familiarity with usability test methodologies and statistical analysis is a plus
• Knowledge of medical device design controls and risk management (ISO 14971) is a plus
• Fluent English language skills, written and spoken, German language is a plus

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

• Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements

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.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.