Senior Human Factors Engineer – Medical Devices

Bayer AG; Indianola (PA); On-site; USD 96,000 - 145,000; Full time

Benefits offered by this job

Health care

Vision care

Dental coverage

Retirement plan

Paid time off

Job summary

Bayer AG in Indianola (Pittsburgh, PA) seeks a Staff Human Factors / Usability Engineer to support cross-functional device development teams, applying user-centric development principles across Radiology and Pharma portfolios.

The role requires strong HF/UE expertise, regulatory knowledge (FDA/Bayer standards), and excellent communication in English, with responsibility for usability evaluations, risk analyses, and design history documentation.

Qualifications

• Master’s degree in engineering sciences, ergonomics, psychology, human factors, biomedical engineering, or related field with at least 4 years HF/UE experience; or Bachelor’s with at least 7 years HF/UE experience.
• Experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development for regulated medical devices.
• Experience contributing to HF/UE submissions and interactions with regulatory bodies, especially US FDA.
• Solid background in user-centric design, design controls (CFR 820.30, ISO 13485), risk management (ISO 14971), EU MDR, and requirements engineering.
• Patient/user advocacy with a solution-oriented mindset; strong English communication; ability to work in a global matrix.

Responsibilities

• Contribute to 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; support HF/UE representation in regulatory consultations.
• Plan usability evaluations across the lifecycle and lead or oversee them (exploratory to post-market).
• Lead/assist use-related risk analyses (URRA, UFMEA) to inform critical tasks and validation planning.
• Contribute to devices development activities, including requirements engineering, UI design, verification & validation planning and execution.
• Document HF/UE results for DHFs and submission dossiers with accuracy.
• Stay current with industry trends and continuously improve HF/UE activities.
• Foster a user-centric mindset across Bayer’s organization.

Job description

Bayer AG in Indianola (Pittsburgh, PA) seeks a Staff Human Factors / Usability Engineer to support cross-functional device development teams, applying user-centric development principles across Radiology and Pharma portfolios.

The role requires strong HF/UE expertise, regulatory knowledge (FDA/Bayer standards), and excellent communication in English, with responsibility for usability evaluations, risk analyses, and design history documentation.