BD · 3 months ago
Human Factors Engineer - Remediation Focus
United States
Full-time
Remote
Senior Level, Lead/Staff
$166K/yr - $273K/yr
10+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health solutions. The Human Factors Engineer will lead remediation-focused activities for legacy product families, applying human factors principles to enhance product safety and compliance.
Health CareMedical DeviceTechnical Support
Responsibilities
Lead and execute all facets of Design Validation & human factors remediation for legacy product families, including planning, documentation, and testing
Develop & execute global Design Validation & Human Factors strategies for successful submission in concert with Regulatory Affairs
Conduct gap analyses of existing DVal/HF documentation and identify areas requiring remediation to meet current regulatory expectations
Lead 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 and User Needs, to ensure traceability
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
Provide HF and usability support to R&D teams throughout the product lifecycle
Experience with Discovery and early-stage product development research to drive design decision
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
Qualification
Required
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% based on business needs
Minimum 10+ years of experience in human factors engineering within regulated healthcare environments
Deep knowledge of User Needs development and primary research
Complete understanding of medical device Design Controls process
Preferred
15+ yr 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
Functional/cross-functional team management experience
Benefits
Competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
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