Human Factors / Usability Engineer

Crystal Equation; Thousand Oaks (CA); Remote; USD 99,000 - 106,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Dental insurance

Vision insurance

Life insurance

401K

Parental leave

Job summary

Crystal Equation Corporation is seeking a Remote Human Factors Engineer/Usability Engineer to lead planning, research, and iterative design of drug-delivery devices in a regulated setting.

You will collaborate across engineering, design, safety, quality, and regulatory teams to translate user needs into UI requirements and to support regulatory submissions with robust HFE/UE methods.

Qualifications

• Master09s degree in Human Factors Engineering, Usability Engineering, or related field with 102 years of regulated medical device/biotech experience, OR Bachelor09s degree with 202 years of experience.
• Experience with FDA/HFE guidance, IEC 62366, ISO 14971, MDR and design controls is preferred.

Responsibilities

• Translate user requirements into UI requirements across programs.
• Support usability activities: study planning, protocol development, moderation, data collection, IRB submissions, and recruitment.
• Ensure HFE/UE input on system requirements across functions for product design, packaging, labeling, and training.
• Improve device-user interfaces and reduce use errors through design and labeling considerations.
• Analyze usability data to inform design, risk minimization, and alternative controls.
• Prepare documentation for design controls, DHF/DMR, risk assessment, and regulatory submissions.
• Communicate with internal and external stakeholders.
• Apply regulatory guidance and standards in project work.

Skills

HFE planning

Research execution

Cross-functional collab

Data analysis

Regulatory submissions

Education

Master09s degree in Human Factors Engineering

Bachelor09s degree in related field

Job description

Human Factors Engineer / Usability Engineer Remote

What you will do:

In this vital role you are responsible for supporting HFE/UE planning, research, development and continuous improvement of 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.

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 our 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.

Basic Qualifications

• Master’s degree in Human Factors Engineering, Usability Engineering, or related Psychology and/or Industrial Design domains plus at least 1-2 years’ experience working in the regulated medical device and/or biotech industry. OR Bachelor’s degree and at least 2-3 years of Human Factors Engineering/Usability Engineering experience working cross-functionally in the regulated medical device and/or biotech industry.

Preferred Qualifications

• 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.
• The position requires 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.

Pay range is $72 - $77 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

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