Senior Risk & HHE Specialist, Ultrasound Devices

Katalyst CRO; Bothell (WA); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking a Risk & Health Hazard Evaluation Specialist to support CAPA and post-market activities for ultrasound systems. The role ensures patient safety and regulatory compliance by evaluating field issues, complaints, and non-conformances.

You will perform HHE assessments, lead risk evaluations per ISO 14971, and collaborate with R&D, QA, and field teams to drive effective risk controls and CAPA actions.

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field.

Responsibilities

• Perform HHE assessments for complaints, field issues, and non-conformances.
• Evaluate patient/user risk and determine severity and likelihood.
• Support regulatory reporting decisions (FDA, EU MDR).
• Conduct and update risk assessments per ISO 14971.
• Maintain and update Risk Management Files (RMF) and related analyses.
• Partner with CAPA teams on root cause investigations and corrective actions.
• Prepare HHE reports, risk assessments, and CAPA documentation.

Skills

Risk assessment

HHE

CAPA integration

Regulatory affairs

Documentation

Education

Biomedical Engineering

Electronics

Job description

Katalyst CRO is seeking a Risk & Health Hazard Evaluation Specialist to support CAPA and post-market activities for ultrasound systems. The role ensures patient safety and regulatory compliance by evaluating field issues, complaints, and non-conformances.

You will perform HHE assessments, lead risk evaluations per ISO 14971, and collaborate with R&D, QA, and field teams to drive effective risk controls and CAPA actions.