BD Nogales Norte
Human Factors Engineer - Remediation Focus
BD Nogales Norte, Franklin Lakes, New Jersey, us, 07417
Overview
Human Factors Engineer - Remediation Focus at BD Nogales Norte. Hybrid on-site role (in-office 4 days per week) located in Salt Lake City, UT; San Diego, CA; or Franklin Lakes, NJ. Primary Responsibilities – Human Factors Remediation
Lead and execute all facets of human factors remediation for legacy product families, including planning, documentation, and testing. Develop & execute global Human Factors strategies for successful submission in concert with Regulatory Affairs. Conduct gap analyses of existing HF documentation and identify areas requiring remediation to meet current regulatory expectations. Support Design Validation activities, including Summative HF 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 HF validation activities are thorough, risk-retiring, and aligned with global regulatory requirements. Update and maintain risk documentation, ensuring traceability between user needs, risks, and design mitigations. Ability to lead and manage cross-functional teams to ensure remediation strategies are appropriately scaled and integrated into program timelines. Prepare and submit HF documentation for regulatory filings, audits, and inspections. Secondary Responsibilities – Broader HF/UX Support
Provide HF and usability support to R&D teams throughout the product lifecycle. Conduct formative evaluations (e.g., heuristic reviews, simulated use studies) to inform design improvements. Plan, lead and execute summative studies. Translate HF findings/data 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 efforts in the medical device or pharmaceutical industry. Deep expertise in design validation, summative usability testing, and risk documentation. Strong understanding of global regulatory HF requirements (e.g., FDA, IEC 62366-1, EU MDR). Ability to independently and autonomously lead, manage and coordinate HF 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. Preferred Qualifications
10+ years experience in Human Factors within the Medical Devices or similar 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. Equal Employment Opportunity: 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information: $113,400.00 - $186,900.00 USD Annual.
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Human Factors Engineer - Remediation Focus at BD Nogales Norte. Hybrid on-site role (in-office 4 days per week) located in Salt Lake City, UT; San Diego, CA; or Franklin Lakes, NJ. Primary Responsibilities – Human Factors Remediation
Lead and execute all facets of human factors remediation for legacy product families, including planning, documentation, and testing. Develop & execute global Human Factors strategies for successful submission in concert with Regulatory Affairs. Conduct gap analyses of existing HF documentation and identify areas requiring remediation to meet current regulatory expectations. Support Design Validation activities, including Summative HF 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 HF validation activities are thorough, risk-retiring, and aligned with global regulatory requirements. Update and maintain risk documentation, ensuring traceability between user needs, risks, and design mitigations. Ability to lead and manage cross-functional teams to ensure remediation strategies are appropriately scaled and integrated into program timelines. Prepare and submit HF documentation for regulatory filings, audits, and inspections. Secondary Responsibilities – Broader HF/UX Support
Provide HF and usability support to R&D teams throughout the product lifecycle. Conduct formative evaluations (e.g., heuristic reviews, simulated use studies) to inform design improvements. Plan, lead and execute summative studies. Translate HF findings/data 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 efforts in the medical device or pharmaceutical industry. Deep expertise in design validation, summative usability testing, and risk documentation. Strong understanding of global regulatory HF requirements (e.g., FDA, IEC 62366-1, EU MDR). Ability to independently and autonomously lead, manage and coordinate HF 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. Preferred Qualifications
10+ years experience in Human Factors within the Medical Devices or similar 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. Equal Employment Opportunity: 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Salary Range Information: $113,400.00 - $186,900.00 USD Annual.
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