Human Factors Engineer/Usability Engineering - Biopharma Medical Device Remote (JP15469)

3 Key Consulting•Thousand Oaks, CA

7d•Remote

About The Position

3 Key Consulting is hiring a Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. In this vital role, you are responsible for supporting HFE/UE planning, research, development, and continuous improvement of the client’s drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product, and bio-pharmaceutical industries. The Human Factors Engineer / Usability Engineer (HFE/UE) is expected to collaborate with internal and external partners and across functions including engineering, design, commercial, safety, risk, quality, regulatory, and market surveillance teams. This person will support human factors research driving innovative, intuitive, and useful products. The HFE will support project study design, HFE/UE methodology, study moderation, data collection, and root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, and product validation in support of regulatory submissions.

Requirements

End to end human factors experience required from planning to validation and reporting
Must be able to demonstrate good technical writing skills
Good communicate skills and experience working with cross functional teams
Minimum experience needed with medical device but most importantly combination product experience

Nice To Haves

Master's degree in Human Factors, HFE/Usability Engineering, or other relevant HF/Engineering discipline and 2+ years of industry experience, working in multi-functional, fast-paced corporate environments.
Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, HF professional analysis, task analysis, hazard analysis, risk assessment, formative and summative studies.
Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs.
Experience using low and high-fidelity prototypes to identify and eliminate potential use errors early in the development process.
Experience working 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.
Good oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
Functional knowledge and experience in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls.

Responsibilities

Work collaboratively with HFE/UE, engineering, design, commercial, and product teams to ensure successful translation of user requirements into products, to create user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across client’s portfolio or programs.
Supporting usability activities such as study planning/coordination/management, protocol development, study moderation, data collection, material development, IRB submissions, participant recruitment, data analysis, and HFE/UE design history file documentation to support project needs.
Collaborate with the HFE/UE lead to ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE/UE input is provided across functions to develop product design, packaging, labeling, and training requirements.
Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.
Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative design controls/solutions.
Support the HFE/UE lead in providing preparation for clinical studies and regulatory submissions in accordance with HFE/UE best practices, guidance and standards.
Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE/UE technical assessments, comparative analysis, HFE/UE reports, data verifications, and regulatory submissions.
Actively communicate with internal and external key stakeholders.
Exercising critical thinking & educated HFE/UE judgement to determine appropriate next steps/actions.
Support core development team(s) on all human factors activities, including attending remote meetings, communicating status to manager on all program requests, developing and recommending HFE strategies, and creating and approving HFE documents within Client's document management system.