The Human Factors / Usability Leader is responsible for performing human factors / usability engineering for full medical device and / or software development projects and pre-projects.
The position will be located within the usability engineering group based in Cambridge, MA, which is part of the global usability engineering team.
The position will report to the Usability Engineering Team Leader in Frankfurt, Germany.
The position will coordinate project activities with multi-disciplinary Sanofi staff in Cambridge, MA; Frankfurt, Germany;
and with partners and consultants across the US and around the world.
The Usability Leader will be responsible for creating, or overseeing the creation of, the usability engineering file within the design history file of development projects.
The Usability Leader will also serve as a Sanofi representative at meetings with the US Food and Drug Administration (FDA) as well as with EMA and notified bodies in Europe.
The job will involve some travel to Frankfurt and to study sites, primarily in the US, Europe and the UK.
Minimum Bachelor’s degree
Experience in human factors / usability engineering for medical devices AND software
Individual is required to have a valid and active passport at time of application
Individual is required to travel outside of the USA, at least once a quarter and at a minimum of a week each time.
2-5 years' experience in human factors / usability engineering of medical devices
Knowledge of human factors methods used within the medical device industry
Knowledge of US and international regulations and standards for medical devices
Familiarity with FDA guidance documents and expectations for human factors / usability engineering of medical devices and combination products
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Experience performing formative and summative evaluation of medical devices, including conducting expert reviews, identifying use-
related risk, drafting test protocols, moderating test sessions, analyzing test data and writing reports of the results
Familiarity with use-related risk management processes and practices for medical devices
Experience working in Agile development processes
Team player and good networker
Responsible, reliable, organized and proactive
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.
All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status;
atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.