Senior Human Factors Engineer – Medical Devices & UX

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

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer is seeking a Principal Engineer - Human Factors for Indianola, PA, to guide cross-functional device development with a strong user-centric approach. You will integrate HF/UE into medical device design, ensure regulatory compliance, and partner with leadership to optimize safety and usability.

The role requires deep HF/UE expertise, successful regulatory submissions, and clear communication in a global matrix.

Qualifications

• Master’s degree in a related field with 7+ years HF/UE experience, or Bachelor’s with 10+ years.
• Experience integrating use-related risk analysis into HF/UE planning and product development.
• Proven HF/UE submissions and interactions with US FDA/regulators.
• Strong background in user-centric design, CFR 820.30, ISO 13485, risk management (ISO 14971) and EU MDR.
• Patient/user advocacy with a solution-oriented mindset.
• Excellent English communication and collaboration in a global matrix.

Responsibilities

• Develop and execute the HF/UE strategy for Bayer’s Radiology and Pharma products; ensure compliance with standards.
• Align HF/UE strategy with regulatory and marketing objectives; manage stakeholder interactions.
• Plan usability evaluations across development lifecycle and lead or oversee execution.
• Lead and facilitate use-related risk analyses (URRA, UFMEA) to inform decisions.
• Contribute to device development activities including requirements engineering and UI design.
• Document HF/UE results for DHF and submissions; ensure accuracy and thoroughness.
• Stay ahead of industry trends and support team learning.
• Advocate for a user-centric mindset across Bayer.

Skills

HF/UE strategy

Regulatory strategy

Use-related risk analysis

User-centric design

Regulatory interactions

Cross-functional leadership

Education

Master’s degree in engineering/related field

Bachelor’s degree with 10+ years HF/UE

Job description

Bayer is seeking a Principal Engineer - Human Factors for Indianola, PA, to guide cross-functional device development with a strong user-centric approach. You will integrate HF/UE into medical device design, ensure regulatory compliance, and partner with leadership to optimize safety and usability.

The role requires deep HF/UE expertise, successful regulatory submissions, and clear communication in a global matrix.