Lead Human Factors Engineer, Medical Devices & Usability

Bayer AG; Indianola (PA); On-site; USD 118,000 - 177,000; Full time

Job summary

Bayer is seeking a Senior Human Factors/Usability Engineer to guide cross-functional device development teams in creating user-centric medical devices and drug-device combinations. The role interfaces with patients, product leadership, clinical, and engineering teams to enhance safety and usability.

The successful candidate will integrate HF/UE principles across Radiology and Pharma portfolios, ensure regulatory compliance (FDA, EU MDR, ISO standards) and contribute to Bayer’s business strategy.

Qualifications

• Master’s degree in engineering, ergonomics, psychology, human factors, biomedical engineering, or related field with HF/UE experience.
• Experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development for regulated devices.

Responsibilities

• Develop and execute the HF/UE strategy for Bayer’s Radiology and Pharma products, ensuring compliance with procedures and standards.
• Align HF/UE strategy with regulatory strategies and marketing objectives; manage stakeholder interactions and represent HF/UE in regulatory consultations.
• Plan usability evaluations across the development lifecycle and lead or oversee their execution (exploratory, formative, summative, post-market).
• Lead and facilitate URRA, UFMEA, and other use-error analysis to inform critical task identification and HF validation strategy.

Skills

HF/UE expertise

Regulatory liaison

English communication

User-centric design

Education

Master’s degree in engineering sciences/related field

Bachelor’s degree + 10+ years HF/UE experience

Job description

Bayer is seeking a Senior Human Factors/Usability Engineer to guide cross-functional device development teams in creating user-centric medical devices and drug-device combinations. The role interfaces with patients, product leadership, clinical, and engineering teams to enhance safety and usability.

The successful candidate will integrate HF/UE principles across Radiology and Pharma portfolios, ensure regulatory compliance (FDA, EU MDR, ISO standards) and contribute to Bayer’s business strategy.