Staff Human Factors Engineer

***New Permanent Role – Staff Human Factors Engineer***
Location – Massachusetts
Salary – $150k & Benefits Package
Industry – Medical Device

My client is seeking a Staff Human Factors Engineer within a new product development organization working on connected medical devices that will transform the health of people living with diabetes.

This Human Factors Engineering role will report to the Senior Manager of Human Factors Engineering & User Experience Design and represents the team on cross functional projects as the Human Factors Engineering subject matter expert.

RESPONSIBILITIES:

Generative Research & Front-End Innovation:
  

• Lead generative human factors research efforts including but not limited to observational research, contextual inquiries, and ethnography.
• 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

• Design, plan, execute, and report usability evaluations including, but not limited to heuristic evaluations, expert reviews, and simulated use walk-throughs (internal evaluations)
• 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
• 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

• Develop 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)
• 7+ years of technical experience in Human Factors Engineering

KNOWLEDGE, SKILLS AND ABILITIES:

• 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 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 62366-1
• FDA Final Guidance for Applying Human Factors and Usability Engineering to Medical Devices (2016)
• 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 which include outside partners and/or internal teams of cross-functional stakeholders
• Strong creative, analytical and problem-solving skills
• Strong technical judgement and interpersonal skills
• Strong 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