Description
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 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.
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.
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;
- 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.
Benefits
- Salary between $117,760.00 to $176,640.00
- Additional compensation may include a bonus or incentive compensation
- Health care, vision, dental, retirement, PTO, sick leave, etc.