Senior Human Factors Engineer: Device UI & Usability Lead

BioSpace; Thousand Oaks (CA); Presencial; USD 140.000 - 190.000; Tempo integral

Benefícios oferecidos por esta vaga

Retirement plan

Stock options

Paid time off

Flexible work models

Resumo da vaga

Amgen is seeking a Senior Human Factors Engineer to lead HF/UE planning, research, and development for drug delivery devices. The role involves guiding studies, coordinating with internal teams, and ensuring compliance with HF regulations and standards.

You will drive usability research, analyze data, and support regulatory submissions. Expect collaboration across engineering, risk, QA, and manufacturing to deliver safe, intuitive products that meet patient needs.

Qualificações

• Doctorate or Master’s degree with substantial Human Factors/Usability Engineering experience in biomedical/medical device fields.
• Bachelor’s degree with 4+ years of HF/UE experience in biomedical/medical device field.
• Associate’s degree with 8+ years in HF/UE in biomedical/medical device field (alternative pathways)
• High school diploma/GED with 10+ years HF/UE experience in biomedical/medical device field.

Responsabilidades

• Lead HF/UE planning, research, development, and continuous improvement of drug delivery devices.
• Manage formative and summative HF studies, including moderation and analysis of data.
• Prepare HF documentation for design controls, DHF/DMR, URRA, and regulatory submissions.
• Collaborate cross-functionally with engineering, risk, quality, regulatory, and marketing to ensure safe, effective devices.

Conhecimentos

HF/UE planning

Usability studies

Regulatory submissions

Cross-functional collaboration

Risk assessment

Formação

Doctorate in relevant field

Master’s in Human Factors or related

Bachelor’s in related field

Descrição da vaga

Amgen is seeking a Senior Human Factors Engineer to lead HF/UE planning, research, and development for drug delivery devices. The role involves guiding studies, coordinating with internal teams, and ensuring compliance with HF regulations and standards.

You will drive usability research, analyze data, and support regulatory submissions. Expect collaboration across engineering, risk, QA, and manufacturing to deliver safe, intuitive products that meet patient needs.