Human Factors Engineer - Remediation Focus

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BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The HF/UX (Human Factors/User Experience) Team within the Medication Delivery Solutions (MDS) business unit is seeking a DVal/Human Factors Engineer to lead and execute remediation‑focused activities for legacy product families. This individual contributor role will be responsible for applying evidence‑based human factors principles to reduce use‑related risks, ensure regulatory compliance, and support product safety and effectiveness.

Location:

Remote role within the United States.

At Medication Delivery Solutions, we are committed to enhancing patient and clinical outcomes by transforming parenteral medication preparation and administration. We focus on:

• Eliminating complications
• Reducing cost
• Improving safety for patients and providers
• Enabling access to better care around the world

Our products are used in hospitals, outpatient centers, clinics, and public health agencies, with over 15 billion units delivered annually.

• 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.
• 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.
• Collaborate with Regulatory Affairs and Systems Engineering to ensure HF validation activities are thorough and aligned with global regulatory requirements.
• Update and maintain risk documentation and User Needs to ensure traceability.
• 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.
• 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.

• 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 lead, manage, and coordinate HF activities across internal teams and external contractors.
• Excellent written and verbal communication skills, with 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.

• 15+ years experience in Human Factors within the medical device or similar space.
• Experience with combination products, software…