Location
Cambridge, MA | United States
Job description
ABOUT THE ROLE:
Global Device & Packaging Unit is a global business Unit in Sanofi M&S which develops and maintains Sanofi`s parenteral injection systems like Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems and Pre-Filled Syringes. The Unit is a project-centric organization which is executing development and LCM projects of drug delivery devices for mAbs, vaccines, peptides, genomics etc. and supports device product maintenance post launch.
The GDPU Lead of Human Factors & Usability Engineering is fully accountable for leading, overseeing and directing all GDPU User Needs and Usability Engineering activities with a specific focus on enhancing patient experience and minimizing the impact on patients.
Your expertise in human factors engineering, usability and user-centered design principles will be crucial in ensuring the safe and effective use of our medical devices and drug device combination products (such as Autoinjectors, Safety-Syringes, Pens etc) by healthcare professionals and patients. Usability engineering includes the development of User Needs and User Requirement as well as executing the respective user studies. The analyses of user Feedback from Studies, Patient associations and open sources like literature, Internet or else and transferring this in requirements and specification an essential skill you master. All Devices and related material like packaging, co-packed component, Instructions for use and related training materials must include usability engineering principals to make our product intuitive and easy to use.
JOB RESPONSIBILITIES:
· Is accountable our injection devices and the related user requirements get developed and engineered for best efficacy when delivering the drug.
· Applies senior knowledge to the Usability Development process and oversees and directs the User Needs development. Provides expertise for novel and innovative input to develop and continues improve our UE processes and procedures.
· Ensure that all devices undergo usability/human factors testing, as appropriate, including formative evaluations during device development and human factors validation testing toward the end.
· Plan and conduct usability studies and evaluations to identify and address user needs, preferences, and potential use errors.
· Collaborate with cross-functional teams, including development engineers, designers, and clinicians, to gather feedback and optimize device design and functionality and to integrate human factor considerations.
· Champion user-centered design methodologies - Is accountable to deliver an effective and efficient product validation strategy whether its summative testing or by other appropriate measures.
· Conduct comprehensive human factors risk assessments to identify and mitigate potential use-related hazards
· Ensure that rules and regulations for medical devices, as promulgated by Regulatory Authorities and relevant to the group, are taken into account during device development, as appropriate.
· Makes sure the right usability development strategy will be chosen in regard to the kind of study, location and country according the regulation needs
· Ensure that all relevant international (e.g. ISO, IEC) and national (e.g. AAMI, EN) standards are taken into account during the device development process, as appropriate. And that harmonized approaches to usability/human factors engineering, risk management and design engineering within the project teams by promoting tools, ideas solutions for best usability.
· Establishes and maintains related Sanofi processes and procedures related to UE
· He/She and the team is accountable to provide adequate documentation from UE development which can be utilized in submission files.
Basic Qualifications:
· Bachelor's, Master's degree or PhD in Human Factors Engineering, Industrial Design, Biomedical Engineering, Mechanical Engineering or a related field with high acumen in usability engineering. In addition, advanced qualification in UE is an advantage.
·8 years’ advanced experience in Usability Engineering and Usability Testing
·5 years in the field of Medical Devices
·5 years leadership experience of international teams
· Proven Experience (5y) in FDA, EMEA (and other regulators) submissions and related
· Experience with working under ISO 13485, CFR 820, IEC 62366, ISO 62304.
· GxP responsibility to provide data and reports for authority submission and approvals. Stand-in in authority and quality audits.
· Sound Experience in interacting with Authorities and Notified Bodies
· Working with international and cross-functional teams
· Working with external partners and suppliers
· Sound understanding of parenteral packaging systems, e.g. syringes or cartridges and the devices which operating those
Preferred Qualification:
Advanced Knowledge of FDA regulations and guidance related to human factors engineering in medical devices (e.g., FDA Human Factors Guidance)
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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