Sr. Human Factors & Usability Engineer

The Sr. Human Factors Engineer (HFE) / Usability Engineer (UE) is responsible for leading HFE / UE planning, research, development 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.

Collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams.

Implement human factors research driving innovative, intuitive, and useful products. Lead project study design, methodology, data collection, root cause analysis to inform design.

Apply sound HFE / UE knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions.

Responsibilities

The Sr. HFE / UE responsibilities include but are not limited to :

Lead and / or conduct to usability activities such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation to support project needs.

Ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE / UE / ID input is provided across functions to develop device 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 solutions.

Work collaboratively with engineering, design, commercial, and product teams to ensure successful translation of customer requirements into products that are safe and effective for user and enrich the overall user experience across Amgen portfolio or programs.

Support and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices.

Actively communicate with internal and external key stakeholders.

Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions.

Apply systematic risk-based process including identifying potential use-related hazards, mitigating those risks, and validating the risk mitigations are effective.

Conduct comprehensive use-related risk analysis (URRA) to ensure that all use-related risks have been mitigated and reduced to an acceptable level.

Identifying and mitigating known use problems to ensure that the combination product will not be prone to the same user interaction issues upon commercialization.

Basic Qualifications :

Doctorate Degree

Master's Degree & 3 years of Engineering or Operations experience

Bachelor's Degree & 5 years of Engineering or Operations experience

Associate's degree & 10 years of Engineering or Operations experience

High school diploma / GED & 12 years of Engineering or Operations experience

Preferred Qualifications :

Master’s degree in Human Factors, Human-Computer Interaction, Industrial Design, Cognitive Psychology, and 6+ years of business experience, working in development organizations in multiple parallel and virtual development environments

4+ years experience working within the development of electro-mechanical systems design, verification and validation

Excellent organizational, technical problem solving and interpersonal skills (written and verbal), the ability to work in teams, adapt to a constantly evolving environment, and lead external design consultants

Leading authority of principles and industry application of Medical Device and healthcare regulations including : FDA’s Human Factors Guidances, Labeling for home use, 14971, 62366.

HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Guidance on Medical Device Patient Labeling;

Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15

HF / ID experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive / minimally invasive drug delivery systems (e.

g. pulmonary, transdermal)

Experience working directly with customers 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.

Proven experience using low and high fidelity prototypes to identify and eliminate potential use errors early in the development process

Amgen offers a very robust compensation and benefits package and is an Equal Opportunity employer. Amgen will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,

or disability status.