Human Factors Engineer - ISO 14971, IEC 60601, IEC62366, GUI, User Research, FDA
Resiliency LLC
Cambridge, MA
Human Factors Engineer - ISO 14971, IEC 60601, IEC62366, GUI, User Research, FDA
Resiliency LLC
Cambridge, MA
- Contractor
Job Description
Company Info
Hybrid - This position offers a hybrid work schedule requiring you to be in the office 3 days a week and an option to work from home two days out of the week (unless a specific business need arises requiring in-office attendance on other days). Note that work schedules and office reporting requirements may change from time to time based on business needs.
Ability to travel up to 10% nationwide.
Individuals must possess a clean valid state driver's license to obtain the position.
This position requires driving, therefore a valid driver's license and acceptable driving record are necessary. Additionally, because this position requires driving for company business as an essential function of the job, it must remain in compliance with company safety guidelines and policies
Job Summary
Client is a Cambridge, MA dedicated to developing innovative medical products. BIC is looking for an experienced, enthusiastic human factors engineer who wants to develop user interfaces for cutting edge medical devices. This human factors engineer will be part of a cross-functional product development team which collaborates with clinicians and hospital staffs across the country to define and validate user requirements.
Key Responsibilities (“Do”):
• Leads usability testing to understand users, use environments, and user characteristics.
• Collect and analyze user behavior through lab studies, field visits, ethnography, and surveys.
• Develop designs and hardware/software requirements for innovative user interfaces.
• Support the documentation and organization of activities needed to achieve 510k approval.
• Work with multi-disciplinary teams made up of engineering, marketing, quality, legal, and manufacturing.
• Incorporate best practices from human factors and user interface design.
• Develops and maintains an understanding of the latest information regarding usability/human factors
testing for medical devices.
• Work with outside vendors and consultants.
Results Expected (“Deliver”):
• Identify, define, and document user interface for a medical device product.
• Create, document, and execute usability test protocols.
• Document test reports in accordance with the Canon documentation standard operating procedures.
• Disclose documented inventions to the patent team.
Qualifications:
• Bachelor’s degree in human Factors Engineering or other appropriate field with a human factor
concentration.
• 3 years of demonstrated experience developing GUI and conducting user research.
• Knowledge of ANSI HE75, ISO 14971, IEC 60601, IEC62366
• Experience moderating user studies.
• Excellent English written and oral communication skills.
Nice to Have
• M.S. or PhD in Human Factors Engineering, or other appropriate field with a human factors concentration.
• 5+ years of demonstrated experience developing GUI and conducting user research, preferably in the medical arena.
• Experience in software architecting and software implementation.
• Experience with Balsamiq and Adobe XD.
• Experience working with FDA guidelines.
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