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Senior Human Factors Engineer
3 months ago
Senior Human Factors Engineer
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locations
USA MA - Andover
time type
Full time
posted on
Posted 17 Days Ago
job requisition id
R
embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe.
or follow our social channels on
,
,
and
.
Human Factors Engineers within Embecta's new product development organization work on connected medical devices that will transform the health of people living with diabetes.
Our mission is to ensure that innovative technology and user experience combine into improved health outcomes.This Human Factors Engineering role will report to the Senior Manager of Human Factors Engineering & User Experience Design and works with senior Human Factors Engineers on cross functional new product development projects.
RESPONSIBILITIES:
Generative Research & Front-End Innovation:
Support projects through human factors research including but not limited to observational research, contextual inquiries, and ethnography
Collaboratively distill research findings into themes and insights which drive user needs, design principles, and product requirements
Create effective user profiles, characterize use environments, map workflows, perform task analyses, and draft use cases to help drive system designs which are optimized for human performance
Draft usability focused requirements and specifications based on the physical, cognitive, and sensory capabilities of intended user groups, including the influence of the intended use environment on user capabilities
Conduct competitive usability assessments and comparative heuristic analyses of early innovation concepts
Provide ergonomic, anthropometric, and behavioral data to peers within cross functional development teams seeking input for design requirements and design concepts
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 in partnership with a cross-functional development team
Formative usability evaluations
Support the design, execution, and reporting of usability evaluations including, but not limited to heuristic evaluations, expert reviews, and simulated use walk-throughs (internal evaluations)
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 which 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)
EXPERIENCE & EDUCATION:
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
KNOWLEDGE, SKILLS AND ABILITIES:
Minimum 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 , 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 judgement and interpersonal skills
Some experience with
facilitation/moderation
skills for workshops and group discussions
Working understanding of the End to End Product Development Process
Preferred, but not required:
Master's Degree or PhD in a technical field related to Human Factors Engineering
embecta is an Equal
Opportunity/AffirmativeAction
Employer.
We 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.
About Usembecta 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.
For more information, visit
or follow our social channels on
,
,
andX
.
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