Lead Human Factors Engineer – Medical Devices & Regulatory

Scorpion Therapeutics; Pennsylvania; On-site; USD 150,000 - 210,000; Full time

Job summary

Bayer is seeking a Lead Human Factors / Usability Engineer to guide HF/UE for its radiology and pharma device portfolios, ensuring user-centric design and regulatory compliance.

You will develop and execute HF/UE strategies, manage usability evaluations across the product lifecycle, lead use-related risk analyses, and document outcomes for submissions, while collaborating with multidisciplinary teams based in Indianola, PA.

Qualifications

• Master’s in engineering, ergonomics, psychology, or related field with 7+ years HF/UE experience.
• Experience with IEC 62366-1, FDA HF/UE guidance, ISO 14971, CFR 820.30, ISO 13485, EU MDR.
• Proven regulatory interactions with US FDA for medical devices.

Responsibilities

• Develop and execute HF/UE strategies across product lifecycle.
• Manage usability evaluations throughout the product lifecycle.
• Lead use-related risk analyses.
• Contribute to device design and verification activities.
• Document HF/UE outcomes for submissions.
• Advocate for user-centric practices.

Skills

HF/UE leadership

Regulatory engagement

Cross-functional collaboration

Education

Master’s degree in engineering/ergonomics/psychology or related field

Bachelor’s degree with 10+ years HF/UE experience

Tools

IEC 62366-1

FDA HF/UE guidance

ISO 14971

CFR 820.30

ISO 13485

EU MDR

Job description

Bayer is seeking a Lead Human Factors / Usability Engineer to guide HF/UE for its radiology and pharma device portfolios, ensuring user-centric design and regulatory compliance.

You will develop and execute HF/UE strategies, manage usability evaluations across the product lifecycle, lead use-related risk analyses, and document outcomes for submissions, while collaborating with multidisciplinary teams based in Indianola, PA.