Senior Human Factors Engineer

4 days ago


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

Embecta is a global leader in diabetes care, leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions and partnerships. As a Senior Human Factors Engineer, you will be part of a team that values your opinions and contributions, and empowers you to bring your authentic self to work.

Key Responsibilities
  • Generative Research & Front-End Innovation: Support projects through human factors research, including observational research, contextual inquiries, and ethnography. Collaborate with cross-functional teams to 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 and contributing to use-related risk mitigation efforts.
  • Formative Usability Evaluations: Support the design, execution, and reporting of usability evaluations, including heuristic evaluations, expert reviews, and simulated use walk-throughs. Support the design, execution, and reporting of qualitative and quantitative formative research studies as part of a new product's iterative usability evaluations.
  • Summative Usability Evaluations & User Needs Validation: Support the project lead on summative evaluations. Contribute to validation study protocols and participate with external partners on how to execute formative and summative usability evaluations to ensure the studies meet embecta's needs. Collaborate with Systems and Verification & Validation (V&V) teams during Design Validation to ensure traceable evidence is captured which demonstrates new products meet defined User Needs.
  • Human Factors Engineering Support for Regulatory Submissions: Contribute to 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.
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).
  • Minimum 3+ years of technical experience in Human Factors Engineering, with a minimum of 3 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 ability to present complex ideas to both technical teams and executive leadership.
  • Working experience using relevant usability engineering standards/industry guidance for medical device development (AAMI/IEC 62366-1, FDA Final Guidance for Applying Human Factors and Usability Engineering to Medical Devices, ISO 14971).
  • Experience as either a moderator or notetaker for usability studies with some experience translating Human Factors findings (use errors) into actionable problems that can be solved.
  • Strong creative, analytical, and problem-solving skills.
  • Sound technical judgment and interpersonal skills.
  • Some experience with facilitation/moderation skills for workshops and group discussions.
  • Working understanding of the End-to-End Product Development Process.


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