User Experience Design Expert

7 days ago

Andover, Massachusetts, United States embecta Full time
About the Role

As a Human Factors Engineer at embecta, you will play a critical role in shaping the user experience of our innovative medical devices. Our team is dedicated to ensuring that our products are designed with the user in mind, and we are seeking a skilled Human Factors Engineer to join our team.

Key Responsibilities
  • Generative Research & Front-End Innovation: Lead generative human factors research efforts, including observational research, contextual inquiries, and ethnography. Distill research findings into themes and insights that drive user needs, design principles, and product requirements.
  • Use-related Risk Management: Collaborate with cross-functional project teams to scale the human factors engineering level of effort and respective usability project plans based on use-related risk. Analyze and iteratively evaluate systems for potential use errors, documenting use-related risks (URRAs, uFMEAs, and/or Hazard Analyses) and contribute to use-related risk mitigation efforts.
  • Formative Usability Evaluations: Design, plan, execute, and report usability evaluations, including heuristic evaluations, expert reviews, and simulated use walk-throughs. Design, plan, execute, analyze, and report qualitative and quantitative formative research studies as part of a new product's iterative usability evaluations.
  • Summative Usability Evaluations & User Needs Validation: Serve as the project lead for Summative evaluations. Design validation studies at the protocol level to guide external partners on how to execute summative usability evaluations. Provide project oversight for external human factors testing vendors and act as the project's internal subject matter expert, ensuring high-quality, actionable human factors engineering data is captured, synthesized, and reported.
  • Human Factors Engineering Support for Regulatory Submissions: Develop project-specific human factors strategies that connect to the broader cross-functional team's strategy for regulatory submission. Support regulatory filings with well-documented Human Factors evidence of successful use-related risk mitigation specific to the device and its development (for both FDA and CE mark).
Requirements
  • Bachelor's Degree in a technical field related to Human Factors Engineering (human factors engineering, industrial psychology, biomedical engineering, behavioral psychology, mechanical engineering, industrial design).
  • 7+ years of technical experience in Human Factors Engineering.
  • 4+ years of experience as a Human Factors Engineer supporting medical device development.
  • Self-motivated/self-starter; proactively identifies opportunities/issues early and provides multiple competing approaches to achieve the desired result.
  • Excellent written and verbal communication skills, with the ability to present complex ideas to both technical teams and executive leadership.
  • Working experience applying relevant usability engineering standards/industry guidance for medical device development, including AAMI/IEC, FDA Final Guidance for Applying Human Factors and Usability Engineering to Medical Devices, and ISO 14971.
  • Capable of conducting/moderating usability studies and translating Human Factors findings into user-needs/requirements, and/or design solutions related to the user interface.
  • Experience leading project work streams that include outside partners and/or internal teams of cross-functional stakeholders.
  • Strong creative, analytical, and problem-solving skills.
  • Strong technical judgment and interpersonal skills.
  • Strong facilitation/moderation skills for workshops and group discussions.
  • Working understanding of the End-to-End Product Development Process.
About embecta

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe. We are committed to fostering an inclusive, growth-centered, and rewarding culture that values our employees' opinions and contributions.

We are an Equal Opportunity/Affirmative Action Employer and do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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