Human Factors Engineer, Biopharma Medical Device - Remote

Job Title:

Human Factors Engineer, Biopharma Medical Device – Remote (JP14424)

Location:

Thousand Oaks, CA 91320

Employment Type:

Contract

Duration: 1+ years with likely extensions and/or conversion to permanent

Pay Rate: $70‑80/hr W2 with benefits, or open to market rate DOE.

Note:

This can be fully remote but local to Thousand Oaks, CA is preferred.

Target start date: 9/15/2025

3 Key Consulting is hiring a Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. The role will support the Human Factors Engineering (HFE) team within the broader Combination Product Optimization (CPO) function.

• Human‑Centered Design Integration:
  Partner cross‑functionally with engineering, design, commercial, clinical, regulatory, and quality teams to translate user needs into product design, including 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.

• Human Factors Engineering
• Data Analysis
• Technical Writing

• Advanced degree in Human Factors or Usability Engineering
• Deep knowledge of applicable global guidance and standards, including FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, and relevant device labeling standards
• IEC/ISO: 62366, 14971, 13485
• 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

• No experience in human factors engineering in the medical device or combination product space.
• Less than 5 years of relevant experience.
• No direct human factors hands‑on experience.