Staff Engineer - Human Factors - Indianola

Scorpion Therapeutics; Pennsylvania; On-site; USD 120,000 - 170,000; Full time

Job summary

Bayer is seeking a Senior Human Factors / Usability Engineer to support radiology and pharma device development. You will develop and execute HF/UE strategies aligned with IEC 62366-1 and FDA guidance, plan usability evaluations, and contribute to device requirements, UI design, and V&V.

You will document findings, support regulatory interactions, promote user-centric approaches, and collaborate across Bayer’s global teams; based in Indianola, PA with potential cross-site collaboration.

Qualifications

• Master’s degree or higher in engineering, ergonomics, psychology, or related field.
• Experience with regulated medical device development and regulatory submissions.
• Strong knowledge of IEC 62366-1, ISO 13485, ISO 14971, and EU MDR.
• Excellent written and spoken English communication.

Responsibilities

• Develop and execute HF/UE strategies ensuring compliance with industry standards.
• Plan and lead usability evaluations across product lifecycle.
• Conduct use-related risk analyses (URRA, UFMEA).
• Contribute to device requirements, UI design, and V&V activities.
• Document HF/UE findings for design documentation and submissions.
• Support regulatory interactions and stakeholder engagement.
• Promote a user-centric approach within the organization.

Skills

HF/UE strategy

Regulated devices

FDA guidance

Usability evaluations

URRA UFMEA

UI design

V&V activities

Regulatory interactions

English communication

Global collaboration

Education

Master’s in engineering/ergonomics/psychology

Bachelor’s in related field

Tools

IEC 62366-1

ISO 13485

ISO 14971

EU MDR

Job description

Role

Senior Human Factors / Usability Engineer supporting Bayer’s Radiology and Pharma device development.

Responsibilities

• develop and execute HF/UE strategies ensuring compliance with industry standards and regulations (IEC 62366-1, FDA guidance)
• plan and lead usability evaluations across product lifecycle
• conduct use-related risk analyses (URRA, UFMEA)
• contribute to device requirements, UI design, and V&V activities
• document HF/UE findings for design documentation and submissions
• support regulatory interactions and stakeholder engagement
• promote a user-centric approach within the organization.

Requirements

• Master’s in engineering, ergonomics, psychology, or related field with 4+ years (MS) or 7+ years (BS) HF/UE experience
• expertise in regulated medical device development, risk analysis, and regulatory submissions, particularly with US FDA
• strong understanding of IEC 62366-1, ISO 13485, ISO 14971, and EU MDR
• excellent communication skills in English
• ability to work in a global matrix environment.

High Value

medical devices and combination products in radiology and pharma, with focus on usability, risk management, regulatory compliance, and user advocacy.

Work Setup

based in Indianola, PA, with potential for collaboration across Bayer’s global teams.