Senior Human Factors Engineer – Medical Device Usability

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

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.