Sr. Human Factors Engineer - Boston/Cambridge, MA
📋 Role Overview & Responsibilities
LOCATIONSSan Jose, CACambridge/Boston, MAChadds Ford, PACambridge, UK
POSITION TYPE: Full-Time, On-Site with ability to travel (25%)
IMPORTANT: This position requires a high level of expertise and experience. If you do not meet the qualifications listed below, we encourage you to explore other opportunities that better match your current skills and background.
JOB SUMMARY:As a Senior Human Factors Engineer at ClariMed, you will help innovative companies design safe and usable medical devices by ensuring that user experience is incorporated throughout the design process. You will also consult with established medical device companies to encourage the adoption of Human Factors best practices.
ROLES & RESPONSIBILITIES:Consult with clients to understand new technologies and interpret their needsConduct task analyses and user research studies for new medical device conceptsAuthor and update usability risk analyses, study protocols, and reportsPlan, coordinate, and moderate usability studies, including designing study modelsAnalyze data to identify root causes of observed use errorsContribute to user interface designs by providing guidance, ideas, feedback, and requirementsSupport and prepare justifications for Human Factors strategiesAssist with Quality Management System efforts, including usability engineering processes and deliverablesSupport inquiries, audits, and discussions with regulatory agencies, test labs, and notified bodiesPrepare and deliver Human Factors engineering trainings and webinarsContribute to research and industry awareness through conferences and publicationsMentor interns and junior-level Human Factors engineersLead projects and communicate with key stakeholders
CANDIDATE REQUIREMENTS:M.A./M.S. in Human Factors Engineering or Biomedical Engineering preferred; B.A./B.S. in related fields also acceptableMinimum 5 years of experience in medical device or similarly regulated industryExpertise in usability standards and risk management (IEC 62366-1, ANSI HE75, ISO 14971, FDA Human Factors guidance)Strong understanding of medical device product design and regulatory processesExperience working within a quality system, preferably at a Fortune 500 medical device or pharmaceutical companyProficiency in devising successful human factors strategies for new productsAbility to collect and synthesize large quantities of information into usable communicationsExperience working with diverse user demographicsAbility to travel domestically (up to 25%)
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