Bayer · 1 day ago
Associate Director, Human Factors Engineering
Bayer is a visionary company committed to solving the world’s toughest challenges. They are seeking a highly experienced Senior Human Factors/Usability Engineer to guide cross-functional device development teams in user-centric development, ensuring that medical devices are designed with the user in mind to enhance safety and effectiveness.
BiotechnologyChemicalHealth CareLife SciencePharmaceutical
Responsibilities
Develop and execute the HF/UE strategy for Bayer’s Radiology and Pharma products, ensuring compliance with internal procedures and industry standards
Align HF/UE strategy with regulatory strategies and marketing objectives; manage stakeholder interactions and represent HF/UE in consultations with regulatory bodies
Plan and oversee usability evaluations across the development lifecycle (exploratory, formative, summative, and post-market), both conducted internally or with external HF/UE service providers
Contribute to device development activities, including requirements engineering, risk management, user interface design, and verification & validation (V&V) planning and execution
Document HF/UE results for design history files and submission dossiers, ensuring accuracy and thoroughness
Stay ahead of industry trends and support continuous learning and improvement within the HF/UE team
Advocate for a user-centric mindset across relevant areas of the Bayer organization
Qualification
Required
Minimum of a Master's degree in engineering sciences, ergonomics, psychology, or a related field
Minimum of 7 years of experience in HF/UE for medical devices and/or drug-device combination products, in accordance with IEC 62366-1 and FDA HF/UE guidance
Proven experience in HF/UE submissions as well as in successful interactions with regulatory bodies, especially with the US FDA
Strong 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
Excellent lateral leadership and communication skills in English
Ability to thrive in a dynamic global matrix environment, embracing change and decision-making
Benefits
Health care
Vision
Dental
Retirement
PTO
Sick leave
Company
Bayer
Bayer is a life science company that specializes in the areas of health care and agriculture.
H1B Sponsorship
Bayer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (62)
2024 (71)
2023 (76)
2022 (141)
2021 (138)
2020 (117)
Funding
Current Stage
Public CompanyTotal Funding
$9.34BKey Investors
Bank of AmericaBill & Melinda Gates FoundationTemasek Holdings
2025-09-26Post Ipo Debt· $331.5M
2024-12-06Post Ipo Debt· $5.29B
2022-11-08Grant· $12M
Leadership Team
Recent News
2026-01-09
Company data provided by crunchbase