Senior HFE/UE Engineer — Medical Device Usability Lead

Amgen Inc.; Cambridge (MA); On-site; USD 129,000 - 175,000; Full time

Job summary

Amgen is seeking a Senior Human Factors Engineer to lead HFE/UE planning, research, and continuous improvement of drug delivery devices. You will partner with engineering, regulatory, quality, and manufacturing teams to ensure safe, effective device interfaces and user-centered design processes.

In this role you will design formative and summative studies, develop URRA analyses, and prepare documentation for regulatory submissions while guiding cross-functional teams toward risk-based,

Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR
• Bachelor’s degree and 4 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR
• Associate’s degree and 8 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field OR
• High school diploma / GED and 10 years of Human Factors Engineering/Usability Engineering experience in the Biomedical/Pharmaceutical/Medical Device Field

Responsibilities

• Partner cross‑functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, commercial to ensure Amgen products are safe and effective for end users.
• Lead and support human factors and usability engineering activities to improve the design of products, specifically the device‑user interface.
• Develop, strategize, and implement a risk‑prioritized, fit‑for‑purpose approach to HF activities.
• Ensure human‑system capabilities and limitations are accurately reflected in the system requirements, and HFE/UE input is provided across functions to develop device design, packaging, labeling, and training requirements.
• Identify, lead, and support appropriate human factors and usability engineering activities to improve the design of device‑user interfaces, including the device, packaging, labeling, and instructions for use to minimize the potential for use errors.
• Analyze objective and subjective data from usability studies to inform product design, identify and mitigate use‑risk, and provide robust solutions.
• Lead the design and execution of human factors formative and summative activities, including moderation, note taking, vendor engagement, and analysis of data.
• Support and provide HFE expertise in preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards.
• Create documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, use‑related risk analysis (URRA), usability technical assessments, HF validation reports, and regulatory submissions.
• Clearly and actively communicate regularly with key internal and external partners.

Job description

Amgen is seeking a Senior Human Factors Engineer to lead HFE/UE planning, research, and continuous improvement of drug delivery devices. You will partner with engineering, regulatory, quality, and manufacturing teams to ensure safe, effective device interfaces and user-centered design processes.

In this role you will design formative and summative studies, develop URRA analyses, and prepare documentation for regulatory submissions while guiding cross-functional teams toward risk-based,