Job Overview

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.

Job Responsibilities and Essential Duties

Front-End Innovation & Formative Research (35%)

• 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.

Use-Related Risk Management & Design Controls (25%)

• 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 1 risks 1 design inputs 1 verification/validation 1 residual risk.
• Contribute to usability architecture decisions for system and accessory interfaces, alarms, workflows, and interop across capital equipment, disposables, and software.

Summative/Validation & Regulatory Support (25%)

• 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.

Cross-Functional Collaboration, Standards Leadership & Mentorship (15%)

• 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.

Minimum Requirements

• 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.

Certifications (Preferred)

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

Required Knowledge, Skills and Abilities

• 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.

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Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 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