Staff Engineer - Human Factors - Indianola

Bayer AG; Indianola (PA); On-site; USD 96,000 - 145,000; Full time

Benefits offered by this job

Health care

Vision care

Dental coverage

Retirement plan

Paid time off

Job summary

Bayer AG in Indianola (Pittsburgh, PA) seeks a Staff Human Factors / Usability Engineer to support cross-functional device development teams, applying user-centric development principles across Radiology and Pharma portfolios.

The role requires strong HF/UE expertise, regulatory knowledge (FDA/Bayer standards), and excellent communication in English, with responsibility for usability evaluations, risk analyses, and design history documentation.

Qualifications

• Master’s degree in engineering sciences, ergonomics, psychology, human factors, biomedical engineering, or related field with at least 4 years HF/UE experience; or Bachelor’s with at least 7 years HF/UE experience.
• Experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development for regulated medical devices.
• Experience contributing to HF/UE submissions and interactions with regulatory bodies, especially 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 English communication; ability to work in a global matrix.

Responsibilities

• Contribute to HF/UE strategy for Bayer’s Radiology and Pharma products, ensuring compliance with procedures and standards.
• Align HF/UE strategy with regulatory strategies and marketing objectives; support HF/UE representation in regulatory consultations.
• Plan usability evaluations across the lifecycle and lead or oversee them (exploratory to post-market).
• Lead/assist use-related risk analyses (URRA, UFMEA) to inform critical tasks and validation planning.
• Contribute to devices development activities, including requirements engineering, UI design, verification & validation planning and execution.
• Document HF/UE results for DHFs and submission dossiers with accuracy.
• Stay current with industry trends and continuously improve HF/UE activities.
• Foster a user-centric mindset across Bayer’s organization.

Job description

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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.

PURPOSE

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).

Key Tasks and 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• 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.

Employees can expect to be paid a salary between $96,480.00 to $144,720.00. 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 applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 10-5-26.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location: United States : Pennsylvania : Indianola