Associate Director, Human Factors Engineering

Bayer•Indiana Township, PA

2d•$128,000 - $192,000

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Associate Director, Human Factors Engineering Associate Director, Human Factors/Usability Engineering We are seeking a highly experienced Senior Human Factors / Usability Engineer to guide cross-functional device development teams in navigating the field of user-centric development. This pivotal role will be at the interface between patients/users, product leadership, commercial, medical/clinical, and engineering teams, ensuring that medical devices and drug-device combination products are designed with the user in mind to enhance safety, effectiveness, and the user experience. The Senior Human Factors/Usability Engineer will integrate Human Factors/Usability Engineering (HF/UE) principles into the design and development of products within Bayer’s global Radiology and Pharma portfolios. This role will leverage user insights to optimize usability, ensure compliance with relevant standards and regulations, and maximize contributions to Bayer’s business strategy. Success in this role requires a deep understanding of user-centric development principles, industry best practices, and regulatory expectations (including those of US FDA, EMA/NBs, UK MHRA, and China NMPA). Effective communication with stakeholders and a commitment to sharing knowledge for mutual growth are essential. You will join a global team of passionate Human Factors/Usability Engineers in a non-managerial role, located in Bayer Radiology R&D, Indianola (Pittsburgh, PA).

Requirements

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.

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.