Human Factors Design Engineer

1 week ago

Boston, Massachusetts, United States Medtronic Full time
About the Role

We are seeking a highly skilled Human Factors Design Engineer to join our team at Medtronic. As a key member of our System Architecture Center of Excellence, you will play a critical role in executing human factors efforts for our Surgical Robotics Organization.

Key Responsibilities
  • Evaluate new designs for fit with surgeons' and OR staff's expectations and abilities, with a particular eye towards safety and ease of use.
  • Administer usability testing, completion of risk analysis for use-related issues, and other human factors program activities that support documentation for the design history file.
  • Lead Human Factors projects supporting business portfolio.
  • Moderate usability testing of prototypes with end users and customers.
  • Aid in data collection and root cause analysis during usability testing.
  • Conduct usability risk analysis.
  • Contribute inputs to design guidance to reduce use risk and improve ease of use.
  • Observe OR procedures and conduct contextual inquiries.
  • Moderate interviews with end users and customers for the purpose of gathering insights.
  • Contribute and maintain human factors program documentation as needed for the UE File.
  • Participate in planning of human factors program activities.
  • Aid in preparing usability-related regulatory documentation for pre-market approval submissions.
  • Aid in identifying use-related issues upon post-market launch and provide recommendations for risk control enhancements.
  • Mentor junior HF staff.
Requirements
  • Bachelor's degree and 4 years of relevant experience.
  • BS in Human Factors or a closely-related field (such as Biomedical Engineering, Industrial Design) with 4+ years' experience; MS or higher preferred with 2+ years' experience.
  • Experience planning, conducting, and documenting usability testing in a medical device use context.
  • Ability to generate design guidance that addresses usability test findings.
  • Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards.
  • Experience with risk analysis as specifically applied to human factors.
  • Prior experience managing outside contractors/agencies preferred.
  • Experience working with complex devices involving both software and hardware preferred.
  • Capable of working independently and with limited oversight in human factors disciplines.
  • Excellent analytical, organizational, oral communication, and written communication skills required.
  • Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask.
  • Interact and communicate with all levels of employees within the Company, as well as suppliers, customers and peers effectively.
  • Comply with policies, procedures, standards and rules of the Company.
  • Maintain quality assurance policy consistent with standards.
  • Maintain work area in a clean, orderly and safe manner.
  • Punctual, regular and consistent attendance.
  • Perform all other job-related duties as assigned.
What We Offer

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees' lives at the core of our values. We recognize their contributions. They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD): 114,400-171,600.

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic is an equal employment opportunity employer and will provide reasonable accommodations for qualified individuals with disabilities.

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