Senior Human Factors and Usability Engineer

Hybrid Details: Onsite in Lawrence minimum 3 days/week may vary, up to 5 days/week in office possible

Duration: 5 months

Job Description

As a Sr. Human Factors and Usability Engineer, you will play a key role in the design, development, use testing, documentation, and launch of our client s Home Hemodialysis and Critical Care product portfolio s flagship products.

You will take part in Human Factors & Usability Engineering activities for new product development programs and contribute to usability improvements for current products (sustaining activities), collaborating with a diverse team of engineers and working in a dynamic, fast-paced environment.

The product portfolio s products integrate mechanical, electrical, software, and fluidic elements, and include interactions with both wet and dry disposables components.

Key Responsibilities

• Serving as a patient / customer advocate in helping our client realize its vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and provide user satisfaction; ultimately supporting our goal of extremely low burden of care!
• Supporting Product Management and Product Engineering personnel in establishing ergonomic, human factors (HF), and usability-related requirements for new products and product line extensions.
• Leading and supporting ethnographic research, usability testing, individual interviews, and group interviews
• Analyzing quantitative and qualitative data to inform design decisions and risk analyses
• Contributing to user interface designs by providing heuristic design guidance, ideas, and feedback to project teams
• Leading documentation review and development, including but not limited to risk analyses, user/environment profiles, task analyses, use specifications and user interface specifications and Human Factors Engineering reports to support regulatory filings
• Drafting uFMEAs and Use Error Analyses; identifying potential use-related hazards and determine product use scenarios and critical user tasks
• Analyzing complaints from on-market products for usability-related issues.
• Flexibility with a range of product interfaces from software GUIs, hardware/fluid connectors to workstations
• Representing the Human Factors/Usability Engineering function on core teams for medium to large sized projects
• Mentoring and coaching junior engineers and teams regarding human factors processes and principles
• Collaborating with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations
• Subject matter expertise and implementation of all relevant HF & usability-related standards and guidance documents (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366-1, IEC 60601-1-6, IEC 60601-1-8, FDA Guidances, etc.)
  
  

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  

Education & Qualifications:

• BS in a relevant Engineering discipline (or equivalent in a technical/scientific field); MS is a plus.
  
  

Experience and Required Skills:

• Subject matter expertise and experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366-1, and ISO 14971.
• 6 years experience in Human Factors / Usability engineering with a BS or 5 years experience with a MS or PhD
• Medical device or combination product design, development, or testing is a requirement (experience with class II or III medical device products is preferred)
• Ability to communicate and present effectively
• Ability to interface with customers in a highly professional manner
• Excellent technical communication skills and attention to detail, including creating and editing technical research, analyses, protocols, and reports
• Ability to analyze and synthesize large quantities of information into usable communications.
• Ability to prioritize and multi-task in a fast-paced, collaborative work environment
• Basic understanding of system, electrical, and mechanical design, as well as software integration.
• Prior experience with complex electro-mechanical systems preferred, especially systems having fluidic and/or disposable components is a bonus
• Experience leading: formative and summative usability evaluations (structuring, recruiting for, conducting, and reporting on), especially involving class II or III medical devices
• Experience working with third-party service providers and external certification laboratories is a bonus