Principal Engineer Human Factors Indianola, PA

At Bayer were visionaries driven to solve the worlds toughest challenges and striving for a world where Health for all Hunger for none is no longer a dream but a real possibility. Were 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 youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference theres only one choice.

Principal Engineer - Human Factors - Indianola PA

Principal Engineer - Human Factors Indianola PA

PURPOSE

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 Bayers 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 Bayers 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).

Your Tasks and Responsibilities

• Develop and execute the HF/UE strategy for Bayers 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.

WHO YOU ARE

Bayer is seeing an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Masters 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 Bachelors 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.

Employees can expect to be paid a salary between $117760.00 to $176640.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care vision dental retirement PTO sick leave etc..

This salary range is merely an estimate and may vary based on an applicants location market data/ranges an applicants skills and prior relevant experience certain degrees and certifications and other relevant factors.

This posting will be available for application until at least.