Boston Scientific Principal Human Factors Engineer 

United States, Minnesota, Maple Grove 

489931805

Your Responsibilities Include:

• Understanding the clinical domain and technical knowledge of the system/device to be evaluated.
• Leading Task Analysis activities.
• Contributing to cross-functional discussions on Use Error Analysis.
• Participating in cross-functional discussions to develop a Use Specification.
• Contributing to the project’s Usability Engineering plan.
• Designing and coordinating internal personnel for Subject Matter Expert (SME) review of concepts at varying levels of fidelity.
• Leading, moderating, analyzing data, and reporting on any formative/summative studies performed.
• Analyzing data from formative studies and writing reports.
• Planning formative and summative usability studies based on results from SME reviews.
• Working with the Study Coordinator when recruiting Health Care Professionals for testing.
• Authoring the Human Factors/Usability Engineering Summary Report.

Minimum Qualifications:

• BS in Human Factors Engineering or a related field.
• Three (3) years of experience with medical device quality systems and developing Class II or Class III medical devices.
• Demonstrated knowledge, skills, and abilities in integrating human factors throughout the systems engineering lifecycle.
• Ten or more years of experience in Human Systems Integration or Human Factors Engineering performing the following:
  • Writing Usability Engineering Plans.
  • Task Analysis & Use Error Analysis.
  • Requirements development.
  • Authoring usability protocols, screeners, and moderator guides.
  • Study execution (formative and summative), including moderation, data collection, and simulated use testing.
  • Ability to analyze data and write reports.
  • Anchoring findings and recommendations in consensus national and international standards for usability and human-centered design.
  • Risk assessment and trade-off analyses in all phases of the systems engineering lifecycle.
  • Writing Human Factors/Usability Engineering Summary Reports for FDA submission.
• Strong verbal and written communication skills.
• Travel to the MN facility will be required.
• US & International travel will be required for study execution.

Preferred Qualifications:

• Master of Science Degree in Human Factors Engineering or a related field.
• Board Certification in Human Factors (i.e., via Oxford Research Institute or Board of Certification in Professional Ergonomics).

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.