# Principal Engineer - Human Factors - Indianola, PA

**Company**: Pharmaceuticals
**Location**: Indianola, Pennsylvania
**Experience**: senior
**Job type**: full-time
**Salary**: $117,760.00 to $176,640.00
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://talent.bayer.com/careers/job/562949978534894?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_77aab263-d1e

## 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.

## Skills

### Required
- Human Factors
- Usability Engineering
- IEC 62366-1
- FDA HF/UE guidance
- User-centric design
- Requirements engineering
- Design controls
- Risk management

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Source: [Apply at talent.bayer.com](https://talent.bayer.com/careers/job/562949978534894?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)