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Sanofi Group Usability Leader, Medical Device Development Unit in Cambridge, Massachusetts

POSITION OVERVIEW

The Usability Leader drives patient-centricity and user-centricity in the user interface design of our devices and combination products. The position’s responsibility is to contribute Human Factors Engineering (HFE) in our development projects (medical devices or combination products) and to ensure that HFE tasks are performed with appropriate rigor and in a timely manner. The primary objective of the Usability Leader’s work are assuring that that the devices

  • are designed to meet user needs and customer expectations,

  • are safe to use, and

  • are compliant with the applicable regulations worldwide.

The Usability Leader will translate insights from exploratory and formative evaluations into user interface specifications and provide user insights to the design team. The Usability Leader provides HFE subject matter expertise to cross functional global teams interacting with experts for industrialization, clinical operations, business, marketing, medical and regulatory affairs.

The position will be located within the human factors/usability engineering team, which is part of Sanofi’s Device Development Unit. It will be located in Cambridge, MA (USA), and will report to the Team Leader Usability Engineering.

Responsibilities :

  • Plan, prepare and perform usability engineering (acc. FDA Guidance on Human Factors Engineering for Medical Devices, AAMI HE 75, IEC 62366-1:2015, and NMPA draft guidance) according to project stages following internal procedures, processes and external requirements for development products.

  • Exploratory Human Factors evaluation(s) in early development.

  • Ensure that usability engineering principles are applied throughout the product development process and in adherence to company design controls principles.

  • Ensure harmonized approach to usability engineering is achieved within the project teams by means of interchanging between projects with other team members and the promotion of common tools and ideas within the teams.

  • Coordinate work packages supplied by usability vendors.

  • Participate in appropriate training and support programs (e.g. professional associations, conferences & symposiums).

  • Ensure that usability engineering documentation is prepared in a timely manner and that they are in accordance with applicable guidelines and standards.

  • Support the link between risk management and device design (esp. user interface) development.

Basic Qualifications:

  • Relevant higher education, e.g. University degree

  • High self-motivation and self-starting attitude and drive

  • Strong interest in and empathy for patients’ needs, user-centric mind set.

  • Very good command of written and spoken English.

  • Several years of work experience with user centered design methods, industry standards and trends within usability engineering and medical devices

  • Good communication and moderation skills and sensitivity are key aspects to keep good working relationship with the different sites and global functions

  • Willingness to travel regularly to human factors study sites, primarily in the US, to Europe or China.

Preferred Qualifications:

  • At least 5 years of experience in the development of medical devices or combination products and the application of related international regulations and standards.

  • Very good knowledge of Usability Engineering

  • Experience in user-centric activities, ideally direct participation in human factors/usability engineering activities for medical devices.

  • Experience presenting to a large range of stakeholders up to senior management level.

  • Good knowledge of international usability standards and guidances, e.g.:

  • ANSI/AAMI/IEC 62366-1

  • EN ISO 14971

  • ANSI/AAMI HE75

  • FDA Guidance on Human Factors Engineering for Medical Devices

  • NMPA Draft Guidance on Human Factor Design

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.

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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.

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