Human Factors Engineer

• *** is seeking a results-driven and experienced Human Factors / Usability Engineer (HF/UE) contractor to support the Human Factors Engineering (HFE) team within the broader Combination Product Optimization (CPO) function. This role is critical in ensuring our drug delivery systems and combination products meet the highest standards of usability, safety, and regulatory compliance.
• This individual contributor will play a hands-on role across the product lifecycle, from early-stage user research through design input, usability testing, and preparation for FDA and global regulatory submissions.
• The ideal candidate will thrive in a fast-paced, matrixed environment and bring deep domain expertise in medical devices, combination products, and FDA-regulated usability engineering.

• Human-Centered Design Integration: Partner cross-functionally with engineering, design, commercial, clinical, regulatory, and quality teams to translate user needs into product design, including user interface (UI) requirements, labeling, packaging, and instructions for use.
• Usability Research Execution: Lead or support usability activities such as study design, protocol development, IRB submission, participant recruitment, data collection, moderation, analysis, and reporting for formative and summative studies.
• Use Risk Mitigation: Conduct comprehensive task analyses, root cause investigations, and use-related risk analyses to inform product design and identify use-related risks.
• Cross-Functional Influence: Serve as a key liaison between HFE and program team functional stakeholders to ensure human capabilities and limitations are reflected in product architecture and usability requirements, and human factors activities are considered at all stages of the product design lifecycle.
• Regulatory Readiness: Support the creation of HF documentation for regulatory submissions including HFE protocols/reports, URRAs, and other components of the overall HF File, all in accordance with global standards and FDA guidance.
• Stakeholder Engagement: Actively communicate and align with internal and external stakeholders to ensure user-centric solutions are embedded across development programs.

• Doctorate OR
• Master's degree and 3+ years of experience in HF/UE within the medical device, combination product, or biopharmaceutical industries OR
• Bachelor's degree and 5+ years of relevant experience

• Advanced degree in Human Factors or Usability Engineering
• Deep knowledge of applicable global guidance and standards:
• o FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, relevant device labeling standards
• o IEC/ISO: 62366, 14971, 13485
• o Other: HE:75, EU MDR Annex 1, additional relevant international device labeling and usability engineering standards
• Proven track record supporting both formative and summative usability studies for combination products and injectors (e.g., pens, autoinjectors, on-body delivery systems)
• Experience with early concept evaluations, use-risk analyses, and iterative design refinement
• Demonstrated ability to influence technical design decisions with a deep understanding of user behavior and cognitive workload
• Technical fluency across disciplines-capable of translating human factors insights for engineering, clinical, software, and regulatory audiences
• Experience contributing to HF sections of FDA pre-submissions, IND/IDE, NDA, BLA, and global regulatory dossiers
• Strong communication, critical thinking, and problem-solving skills in a collaborative environment
• Able to manage ambiguity, prioritize competing deadlines, and drive user-centered design in a global organization.

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