Principal Engineer - Human Factors - Indianola, PA

Bayer•Indianola, PA

2d•Onsite

About The Position

We are seeking a highly experienced 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 Principal 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 as a senior individual contributor within Bayer Radiology R&D, based in Indianola (Pittsburgh, PA).

Requirements

Master’s degree in engineering sciences, ergonomics, psychology, human factors, biomedical engineering, or a related field with a minimum of 7 years of relevant HF/UE experience; or Bachelor’s degree in a related field with a minimum of 10 years of relevant HF/UE experience.
Experience should include HF/UE activities conducted in accordance with IEC 62366-1 and FDA HF/UE guidance;
Demonstrated experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development decision-making for regulated medical devices or combination products;
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, requirements engineering, design controls (CFR 820.30, ISO 13485), risk management (ISO 14971), and applicable global regulatory expectations, including EU MDR;
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 usability evaluations across the development lifecycle and either lead or oversee their execution, including exploratory, formative, summative, and post-market evaluations performed internally or supported by external HF/UE service providers;
Lead and facilitate use-related risk analysis activities, such as Use-Related Risk Analysis (URRA), Use Failure Mode and Effects Analysis (UFMEA), and other structured use-error analysis methods, to inform critical task identification, formative study planning, HF validation strategy, and broader project decisions;
Contribute to device development activities, including requirements engineering, 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.