Human Factors Engineer (Remote) – Combination Product Drug Delivery Devices & Usability Validation - (JP16090)

3 Key Consulting•Thousand Oaks, CA

1d•Remote

About The Position

3 Key Consulting is hiring a Human Factors Engineer for a contract engagement with a leading global biopharmaceutical company. This fully remote role supports human factors engineering and usability engineering planning, research, development, and continuous improvement for drug delivery devices and combination products. Work must follow applicable human factors best practices, regulations, guidance, and standards for the medical device, combination product, and biopharmaceutical industries. The engineer will collaborate with internal and external partners across engineering, design, commercial, safety, risk, quality, regulatory, and market surveillance functions. The role supports research and product development, clinical studies, and product validation for regulatory submissions. It includes contributing to study design and methodology, moderating studies, collecting and analyzing data, and conducting root-cause analysis to inform product design and reduce use errors. The position is open to supplement additional team workload. The engagement is expected to last at least one year, with likely extensions and/or conversion to permanent employment. The listed pay rate is $76–$84 per hour on W2.

Requirements

Master’s degree in Human Factors Engineering, Usability Engineering, or a related psychology or industrial design discipline, plus at least 1–2 years of experience in the regulated medical device and/or biotech industry; or a bachelor’s degree plus at least 2–3 years of Human Factors Engineering/Usability Engineering experience working cross-functionally in the regulated medical device and/or biotech industry.
End-to-end human factors experience, from planning through validation and reporting.
Experience with medical devices; combination-product experience is especially important.
Strong technical writing and communication skills, including experience working with cross-functional teams.
Ability to work in teams, solve technical problems, think critically, stay organized, and adapt to a rapidly changing environment.
Functional knowledge and practical experience applying relevant FDA human factors guidance, regulations, and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls.

Nice To Haves

Master’s degree in Human Factors, HFE/Usability Engineering, or another relevant human factors or engineering discipline, with 2 or more years of industry experience in a multifunctional, fast-paced corporate environment.
Experience with human factors methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, professional analysis, task analysis, hazard analysis, risk assessment, and formative and summative studies.
Experience working directly with users to gather and synthesize research, translate it into concepts, and develop and evaluate product features, user interfaces, and ergonomic designs.
Experience using low- and high-fidelity prototypes to identify and eliminate potential use errors early in development.
Experience in development organizations, particularly virtual development environments, contributing to systems design, verification, and validation milestones.
Ability to communicate effectively with mechanical, electrical, software, clinical, regulatory, safety, risk, and quality engineering disciplines.

Responsibilities

Support core development teams on human factors activities, attend remote meetings, communicate program-request status to the manager, recommend HFE strategies, and create and approve HFE documents in the client’s document management system.
Work with HFE/UE, engineering, design, commercial, and product teams to translate user requirements into products and user interface requirements that meet user needs and support a positive user experience.
Support usability study planning, coordination, and management, including protocol development, moderation, data collection, materials development, IRB submissions, participant recruitment, data analysis, and design history file documentation.
Collaborate with the HFE/UE lead to ensure human-system capabilities and limitations are reflected in system requirements and to provide HFE/UE input on product design, packaging, labeling, and training requirements.
Support human factors and usability engineering activities to improve device-user interfaces, including devices, packaging, labeling, and instructions for use, while minimizing potential use errors.
Analyze objective and subjective usability-study data to inform design and risk minimization and recommend alternative design controls or solutions.
Support preparation for clinical studies and regulatory submissions in accordance with HFE/UE best practices, guidance, and standards.
Prepare development, design-control, DHF, and DMR documentation, including protocols, task analyses, risk assessments, technical assessments, comparative analyses, HFE/UE reports, data verifications, and regulatory-submission materials.
Communicate with internal and external stakeholders and use critical thinking and informed HFE/UE judgment to determine appropriate next steps.