Senior Human Factors Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +2

Senior Human Factors Engineer for DePuy Synthes Orthopaedics team, focusing on user-centered design for medical devices from concept to post-market support. The role involves understanding use environments, user types, and influencing usability activities. Requires collaboration with cross-functional teams and representing the customer's voice.

What you'd actually do

  1. Lead human factors efforts for programs from concept through post market support, supporting and influencing usability activities for product lines and programs with minimal oversight
  2. Develop an understanding of intended use environments gained through time spent in the field, with a good understanding of intended user types formed through interactions with users
  3. Require work on problems of diverse scope that impact the broader program team and business, and contributes to projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations
  4. Network with key contacts outside own area of expertise, contributes information to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development

Skills

Required

  • University/Bachelor's Degree in Human Factors Engineering (HFE), or Usability Engineering
  • 4 to 6 years work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions
  • Demonstrated ability with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions
  • Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation
  • Ability in planning, executing, documenting, and reporting usability testing, including moderation of studies
  • Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering
  • Fluent in English

Nice to have

  • Medical Device product development or experience working in a highly regulated industry is a strong plus
  • Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus
  • Good knowledge of the ISO 14971 and IEC 62304 are a plus
  • German and French are an advantage

What the JD emphasized

  • human factors engineering process
  • medical device product development
  • highly regulated industry