Human Factor Staff Engineer - Wayne, NJ

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Date:
Mar 18, 2026

Location:

Wayne, NJ, US

Remote Work: 1-2 days at home (site based)

Salary Range: 125-150K with 10% STIP

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life‑saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

The Staff Human Factors Engineer 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.

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 → 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.

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.
• 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 TIR
  50/51
  , 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
  , HCI/UX
  , Industrial Engineering
  ,…