Senior Human Factors Engineer (Medical Devices & Usability)

Bayer; Indianola (PA); In loco; USD 96.000 - 145.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health care

Vision

Dental

Retirement

PTO

Sick leave

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Communication in English

Cross-functional collaboration

Regulatory awareness

Formazione

Master’s degree in engineering sciences or related field

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

Strumenti

CFR 820.30

ISO 13485

ISO 14971

IEC 62366-1

Descrizione del lavoro

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.