Engineer- Human Factors Engineer​/Usability Engineer; HF​/UE

Human Factors Engineer / Usability Engineer (HF/UE)

Responsible for supporting HFE/UE planning, research, development, and continuous improvement of Amgen drug delivery devices using best practices and in accordance with current regulations and guidelines within the medical device, combination product and biopharmaceutical industries.

• Collaborate with HFE/UE, engineering, design, commercial, and product teams to translate user requirements into products and create UI requirements that meet user needs.
• Support usability activities such as study planning, coordination, management, protocol development, study moderation, data collection, material development, IRB submissions, participant recruitment, and data analysis.
• Document HFE/UE design history file to support project needs.
• Collaborate with the HFE/UE lead to ensure human-system capabilities and limitations are reflected in system requirements and to provide input across functions for product design, packaging, labeling, and training.
• Improve product design for device-user interfaces, including device, packaging, labeling, and instructions for use, minimizing use errors.
• Analyze objective and subjective data from usability studies to inform design, risk minimization, and provide alternative design controls or solutions.
• Prepare documentation to support development activities, design controls, DHF, DMR, including protocols, task analysis, risk assessment, technical assessments, comparative analysis, reports, data verifications, and regulatory submissions.
• Actively communicate with internal and external key stakeholders.
• Exercise critical thinking and educated HFE/UE judgment to determine appropriate next steps and actions.

This position requires up to 20% yearly local and domestic travel.

• Master’s degree in Human Factors Engineering, Usability Engineering, or related Psychology and/or Industrial Design domains.
• Bachelor’s degree and 2 years of experience working in the regulated medical device and/or biotech industry.
• Associate’s degree and 6 years of experience working in the regulated medical device and/or biotech industry.
• High school diploma/GED and 8 years of experience working in the regulated medical device and/or biotech industry.

• Master’s degree in Human Factors, HFE/Usability Engineering, or another relevant discipline and 2+ years of industry experience in a multi-functional, fast-paced corporate environment.
• Experience with 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 and 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 development.
• 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.
• Strong oral and written communication, organizational skills, technical problem-solving, teamwork, critical thinking, adaptability to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
• Functional knowledge and experience in applying FDA human-factors guidance, regulations, and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls.

Expected annual salary range:  USD -  USD.

• Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.