Base: $106,000.00 to $133,000.00; bonus/equity: el...
Fully remote
Iec 62366 medical device standards
Fda usability engineering guidance application
5+ years medical device experience
The role provides human factors and usability engineering leadership on new product development projects to improve patient outcomes in acute care technology
Job Summary
The role provides human factors and usability engineering leadership on new product development projects to improve patient outcomes in acute care technology.
Responsibilities include planning and executing formative and summative studies, performing use-related hazards analysis, and supporting regulatory submissions for FDA and MDR compliance.
ZOLL offers a competitive salary range of $106,000 to $133,000 with eligibility for an annual bonus and comprehensive benefits plans.
Matching Summary
The role provides human factors and usability engineering leadership on new product development projects to improve patient outcomes in acute care technology.
Salary
Base: $106,000.00 to $133,000.00; Bonus/Equity: Eligible for annual bonus; Benefits: Comprehensive plans available
Skills & Requirements
Must-have
IEC 62366 medical device standards
FDA Usability Engineering guidance application
5+ years medical device experience
4+ years usability engineering specific
Design history file documentation authoring
Nice-to-have
Mentoring less senior team members
Software simulation tool prototype development
Cross-functional collaboration skills
Template development contribution
Self-motivated minimal supervision work style
Key Requirements
BS or MS in Human Factors or Biomedical Engineering
Minimum 5 years total work experience
Minimum 4 years in medical device usability engineering
Practical knowledge of IEC 62366 and 60601-1-6
Experience applying FDA and MDR guidance to design