Engineer- Human Factors Engineer / Usability Engineer (HF/ UE)

Amgen • Cambridge, MA

2d • $103,424 - $139,926

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. In this vital role you are responsible for supporting HFE/UE planning, research, development and continuous improvement of Amgen 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

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

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.
• 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 Amgen’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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level