Staff Engineer - Human Factors - Indianola

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

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer seeks a Staff Engineer - Human Factors to support cross-functional teams in designing safe, effective medical devices and drug‑device products. Based in Indianola (Pittsburgh, PA), you will apply HF/UE principles across the Radiology and Pharma portfolios.

The role requires a strong background in user‑centric design, regulatory frameworks (FDA, CFR 820.30, ISO 13485, ISO 14971, EU MDR), and excellent English communication. Equal opportunity employer with ongoing learning opportunities.

Qualifications

• Master’s degree in engineering sciences, ergonomics, psychology, human factors, biomedical engineering, or a related field with 4+ years HF/UE experience; or Bachelor’s degree with 7+ years HF/UE experience and adherence to IEC 62366-1 and FDA HF/UE guidance.
• Experience integrating use‑related risk analysis into HF/UE planning, validation strategy, and product development 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 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 with external HF/UE service providers.
• Lead and support use‑related risk analysis activities, including URRA, UFMEA, and other structured use‑error analyses, to support critical task identification and HF/UE decisions.
• Contribute to device development activities, including requirements engineering, user interface design, and verification & validation 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.

Skills

Communication in English

Cross-functional collaboration

Regulatory awareness

Education

Master’s degree in engineering sciences or related field

Bachelor’s degree with 7+ years HF/UE experience

Tools

CFR 820.30

ISO 13485

ISO 14971

IEC 62366-1

Job 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’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.

Staff Engineer - Human Factors - Indianola

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).

• Health care
• Vision
• Dental
• Retirement
• PTO
• Sick leave

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

Division: Pharmaceuticals

Reference Code: 886845

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