Title: Associate Director Human Factors Usability and Engineering

Location: Cambridge, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Your job, as Associate Director Human Factors Usability and Engineering, within our Drug Product and Device group, will be 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.

• Develop user needs together with patients, user, and patient/user associations.
  
• Design the product to meet users' needs and customer expectations.
  
• Ensure the product is safe and effective to use and complies with applicable regulations worldwide.
  
• Translate insights from exploratory and formative evaluations into user interface specifications and provide user insights to the design team.
  
• Provide human factors engineering subject matter expertise to cross-functional global teams, interacting with experts in industrialization, clinical operations, business, marketing, medical, and regulatory affairs.
  
• Oversee and participate in design validation and verification activities, including developing protocols, conducting validation testing, reviewing validation reports, and developing engineering reports for regulatory submissions.
  

• Bachelor's degree in human factors/usability or a related field (e.g., biomedical engineering, mechanical engineering, psychology, economics, human-computer interaction, etc.).
  
• Master's degree in human factors/usability or a related field (e.g., biomedical engineering, mechanical engineering, psychology, human-computer interaction) preferred, but not required.
  
• 5+ years of work experience applying human factors to medical devices or combination products.
  
• Strong understanding of human factors research elements (e.g., study design, moderating, root cause analysis).
  
• Familiarity and comfort with navigating health authority expectations for human factors.
  
• Deep knowledge of human factors/usability engineering principles, best practices, and international usability standards and guidance (e.g., ANSI/AAMI/IEC 62366-1, ANSI/AAMI HE75, FDA guidance, NMPA guidance, ISO 14971).
  
• Willingness to travel regularly to human factors study sites, primarily in the US, or to Europe or Asia.
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.