Lead, Human Factors

The Human Factors Lead is a key technical contributor responsible for leading usability engineering across the product lifecycle for cardiovascular surgical devices and systems. This role spans front-end innovation (ethnographic research, workflow analysis, opportunity framing, concept ideation, prototyping, and formative evaluation) and back-end validation (use-related risk analysis, labeling/UI development, clinical simulation, and summative/validation studies) to ensure products are safe, effective, and intuitive in complex clinical environments (OR/cath lab/ICU). The position partners closely with Systems Engineering, Design, Clinical, Marketing, Regulatory, Quality, and Software/Hardware teams to embed human factors and usability engineering into Design Controls and to meet FDA and global regulatory requirements (e.g., IEC 62366-1, ISO 14971). The Staff HFE will serve as a subject-matter resource for cardiovascular use environments, mentoring junior engineers and shaping the usability strategy across programs.

• Lead contextual inquiry, ethnography, and workflow mapping in cardiovascular surgery and interventional settings (OR, hybrid OR, cath lab).
• Translate insights into user needs, intended use, and use specifications; define user personas and critical tasks.
• Drive concept ideation with cross-functional teams; create wireframes, storyboards, and low- to high-fidelity prototypes (software/hardware).
• Plan and execute formative evaluations (simulated-use, heuristic reviews, cognitive walkthroughs), synthesize findings, and iterate designs.
• Partner with Systems Engineering to decompose user needs into requirements and UI specifications with clear traceability.

• Lead use-related risk analysis (U-FMEA, task analysis, link to ISO 14971 hazard analysis); define critical user tasks and mitigations across labeling, UI, hardware controls, training, and software safeguards.
Ensure HF work products align with Design Controls (21 CFR 820.30) and maintain traceability from user needs risks design inputs verification/validation
• residual risk.
• Contribute to usability architecture decisions for system and accessory interfaces, alarms, workflows, and interop across capital equipment, disposables, and software.

• Plan and execute human factors validation (summative) studies per IEC 62366-1 and FDA HF guidance—including sample rationale, representative users, training decay, test protocols, and data analysis.
• Develop labeling and IFU content; ensure clarity of critical information (warnings, precautions, steps, visuals).
• Author HF deliverables for regulatory submissions (e.g., HFE/UE Report, Use Specification, URRA, Critical Tasks, Protocols, Validation Results) supporting 510(k)/PMA/Technical File submissions.
• Support audits, pre-submission interactions, and responses to regulatory queries.

• Partner with Clinical, Marketing, and Design to prioritize unmet needs, value propositions, and KOL/stakeholder feedback.
• Establish and continuously improve HFE methods, templates, and SOP/WI alignment with AAMI HE75, AAMI TIR50/51, IEC 60601-1-6, IEC 62366-2 guidance, and ISO 9241 best practices.
• Mentor junior HF engineers; champion usability and patient/clinician safety while balancing business and technical constraints.

• Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Cognitive/Experimental Psychology, Biological sciences, HCI/UX, Industrial Engineering, or related field required.
• Master’s degree preferred.
• 10+ years of experience in Human Factors leadership/Usability Engineering for complex systems, preferably Class II/III medical devices.
• Demonstrated experience with OR or interventional workflows strongly preferred (cardiovascular surgery, structural heart, electrophysiology, perfusion, imaging, pumps/dispensers, or energy devices).
• Track record delivering both formative and summative studies and authoring HFE documentation for regulatory submissions.

• CHFP, CUXP, or equivalent professional HF/UX certification.
• Additional training in Design Controls, risk management (ISO 14971), or biostatistics is a plus.

• Deep knowledge of IEC 62366-1 (usability engineering for medical devices), FDA HF Guidance (2016, updates as applicable), AAMI HE75, AAMI TIR50/51, IEC 60601-1-6, ISO 14971, ISO 13485, and 21 CFR 820.30.
• Proficiency in use-related risk analysis, task analysis, critical task identification, and linkage to risk controls across UI, labeling, training, and design features.
• Expertise conducting formative and summative usability testing—protocols, IRB coordination (as needed), recruitment, moderation, data capture, and analysis.
• Strong capability in UI/UX prototyping and design collaboration; familiarity with design tokens and component libraries a plus.
• Comfortable working with requirements tools ; experience maintaining traceability to design inputs and risks.
• Experience with clinical simulation environments (wet lab, benchtop, high-fidelity simulators) and human performance data capture.
• Statistical literacy for HF studies (confidence intervals, error analysis, root cause analysis); proficiency with JMP, Minitab, or equivalent is a plus.
• Excellent communication—clear documentation, visual storytelling, and the ability to influence decisions in a matrixed organization.
• Strong judgment, accountability, and attention to detail in safety‑critical contexts.

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement