Human Factors Engineer – Remediation Focus Company: BD (Tissuemed Ltd) Location: Salt Lake City, Utah; San Diego, California; Franklin Lakes, New Jersey. Hybrid on‑site 4 days per week. Job Summary BD is a global medical technology company that advances health. The Human Factors Engineer (HFE) is an expert leader who understands customer emotions and behaviors to uncover meaningful insights that inform design decisions. In this role, you will lead and execute remediation‑focused human factors activities for legacy product families, applying evidence‑based principles to reduce use‑related risks, ensure regulatory compliance, and support product safety and effectiveness. Primary Responsibilities – Human Factors Remediation Lead and execute all facets of human factors remediation for legacy product families, including planning, documentation, and testing. Develop and execute global human factors strategies for successful regulatory submission. Conduct gap analyses of existing human factors documentation and identify areas needing remediation to meet current regulatory expectations. Support design validation activities, including summative human factors validation testing, in collaboration with V&V teams. Evaluate use errors and develop use‑related risk analysis (URRA) and mitigation strategies in partnership with Medical & Regulatory Affairs. Collaborate with Regulatory Affairs and Systems Engineering to ensure validation activities are risk‑retiring and aligned with global requirements. Update and maintain risk documentation, ensuring traceability between user needs, risks, and design mitigations. Lead and manage cross‑functional teams to ensure remediation strategies are appropriately scaled and integrated into program timelines. Prepare and submit human factors documentation for regulatory filings, audits, and inspections. Secondary Responsibilities – Broader HF/UX Support Provide human factors and usability support to R&D teams throughout the product lifecycle. Conduct formative evaluations (heuristic reviews, simulated use studies) to inform design improvements. Plan, lead, and execute summative studies. Translate human factors findings into actionable design inputs, user needs, and risk mitigations. Support training and education efforts to promote human‑centered design across the organization. Mentor junior engineers and participate in internal reviews and workshops. Required Skills & Experience Proven experience leading human factors remediation in the medical device or pharmaceutical industry. Deep expertise in design validation, summative usability testing, and risk documentation. Strong understanding of global regulatory human factors requirements (FDA, IEC 62366‑1, EU MDR). Capacity to independently lead, manage, and coordinate human factors activities across internal teams and external contractors. Excellent written and verbal communication skills, with the ability to present complex findings to diverse audiences. Strong creative, analytical, and problem‑solving skills. Willingness to travel domestically and internationally up to 25–50% based on business needs. Minimum 7+ years of experience in human factors engineering within regulated healthcare environments. Deep knowledge of user needs development and primary research methods. Preferred Qualifications 10+ years experience in human factors within the medical device or related space. Experience with combination products, software interfaces, and hardware systems. Familiarity with post‑market surveillance and clinical evidence generation related to usability.Deep understanding of the end‑to‑end product development process. Innovation framework experience. Internal and external audit experience. Salary Range $113,400.00 – $186,900.00 USD Annually EEO Statement Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and any other legally protected characteristic. We are committed to a diverse and inclusive workforce and provide reasonable accommodations for qualified individuals with disabilities and for religious accommodation. For more information visit #J-18808-Ljbffr BD (Tissuemed Ltd)
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