Senior Human Factors Engineer – Med Device UX Lead

BioSpace; Thousand Oaks (CA); Sur place; USD 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Bonus program

Long-term incentives

Time-off plans

Flexible work model

Résumé du poste

Amgen seeks a Senior Human Factors Engineer to lead HF/UE planning, research, and development of drug delivery devices. This role collaborates across engineering, risk, quality, regulatory, and clinical teams to ensure safe and intuitive user interfaces.

The ideal candidate will design and execute usability studies, analyze data, and drive risk-based decisions. Up to 20% travel may be required, with strong emphasis on regulatory alignment and product safety.

Qualifications

• Doctorate degree or equivalent.
• Master's degree with 2+ years HF Eng experience in biomedical field.
• Bachelor's with 4+ years HF Eng experience in biomedical field.
• Associates with 8+ years HF Eng experience in biomedical field.
• HS diploma with 10+ years HF Eng experience in biomedical field.

Responsabilités

• Lead HF/UE planning, research, and development for drug delivery devices.
• Collaborate with cross-functional teams across engineering, risk, quality, regulatory, and clinical.
• Create documentation to support DHF, DMR, URRA, usability assessments, and regulatory submissions.
• Conduct formative and summative usability studies and analyze results to reduce use errors.

Connaissances

HF Engineering

Usability

Risk Analysis

Formation

PhD

MS+HF Eng

BS+HF Eng

AS+HF Eng

HS+HF Exp

Outils

FDA guidance

IEC 62366

ISO 14971

Description du poste

Amgen seeks a Senior Human Factors Engineer to lead HF/UE planning, research, and development of drug delivery devices. This role collaborates across engineering, risk, quality, regulatory, and clinical teams to ensure safe and intuitive user interfaces.

The ideal candidate will design and execute usability studies, analyze data, and drive risk-based decisions. Up to 20% travel may be required, with strong emphasis on regulatory alignment and product safety.