Human Factors Engineer

The Senior Human Factors Engineer will be responsible for providing human factors engineering expertise to multiple teams across the BWIs catheter portfolio, taking into consideration all aspects of the user experience.

The Senior Human Factors Engineer has strong experience in human factors engineering for medical devices. They will collaborate with cross functional teams including R&D, Marketing, Project Management, Clinical & Medical Affairs and Quality.

They will be responsible for educating and guiding teams through human factors activities and requirements throughout the product development process to ensure devices are safe and easy to use.

Responsibilities:

• Influences HF/Usability strategy and leads human factors efforts for programs from concept through post market support, supporting and influences usability activities for product lines and programs with minimal oversight.
• Will develop a good understanding of intended use environments gained through time spent in the field, and a good understanding of intended user types formed through interactions with users.
• Work on problems of diverse scope that impact broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations.
• Mentor other engineers on project and supervises/directs third party contractors/consultants; including reviews of deliverables to ensure accuracy.
• Network with key contacts outside own area of expertise, contributes to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development.

Requirements

• University/Bachelor's Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology or Equivalent.
• Minimum of 5 years work experience in human factors/usability engineering.
• Hands-on involvement in FDA submissions (PMA, 510(k)) and EU MDR compliance.
• The candidate has demonstrated ability to lead project-level human factors activities, including contextual inquiry, ethnographic studies, requirements definition, use-related risk analysis, formative usability assessments, and summative evaluation studies.
• Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation.
• Expertise in planning, executing, documenting, and reporting usability testing, including moderation of studies.
• Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering
• Good knowledge of the ISO 14971 and IEC 62304 are a plus
• Fluent in English.
• Ability to travel up to 20%, domestic and international is required.
• Experience with data analysis and programming tools e.g. MATLAB, python, r

Nice to Haves

• Clinical experience and/or professional experience/degrees in design development and/or product development is a strong plus.
• Exposure to UX design principles and collaboration with design teams.
• Knowledge of digital interfaces or software usability in medical devices.

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.