Staff Engineer - Human Factors - Indianola

Bayer•Indianola, PA

2d•Onsite

About The Position

We are seeking a skilled Human Factors / Usability Engineer to support cross-functional device development teams in applying user-centric development principles. In this role, you will work at the interface between patients/users, product leadership, commercial, medical/clinical, and engineering teams, contributing to the design of medical devices and drug-device combination products that enhance safety, effectiveness, and the user experience. The Staff Human Factors / Usability Engineer will apply Human Factors / Usability Engineering (HF/UE) principles to the design and development of products within Bayer's global Radiology and Pharma portfolios. This role will leverage user insights to support usability optimization, help ensure compliance with relevant standards and regulations, and contribute to Bayer's business strategy. Success in this role requires a solid understanding of user-centric development principles, industry best practices, and regulatory expectations (including those of US FDA). Effective communication with stakeholders and a commitment to continuous learning and professional growth are essential. You will join a global team of passionate Human Factors / Usability Engineers as an 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 4 years of relevant HF/UE experience; or Bachelor’s degree in a related field with a minimum of 7 years of relevant HF/UE experience.
Experience should include HF/UE activities conducted in accordance with IEC 62366-1 and FDA HF/UE guidance.
Experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development decision-making for regulated medical devices or combination products.
Experience contributing to HF/UE submissions and supporting interactions with regulatory bodies, especially with the 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 communication and collaboration skills in English.
Ability to work effectively in a dynamic global matrix environment, embracing change and supporting team decision-making.

Responsibilities

Contribute to the development and execution of the HF/UE strategy for Bayer's Radiology and Pharma products, ensuring compliance with internal procedures and industry standards.
Support the alignment of HF/UE strategy with regulatory strategies and marketing objectives; assist in stakeholder interactions and support HF/UE representation 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 support use-related risk analysis activities, including Use-Related Risk Analysis (URRA), Use Failure Mode and Effects Analysis (UFMEA), and other structured use-error analysis methods, to support critical task identification, formative study planning, HF validation planning, and product development 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 current with industry trends and actively participate in continuous learning and improvement within the HF/UE team.
Support a user-centric mindset across relevant areas of the Bayer organization.