Senior Verification Engineer, Medical Imaging

KARL STORZ SE & Co. KG; Goleta (CA); Híbrido; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

3 weeks vacation accrual

401(k) match

Descripción de la vacante

KARL STORZ SE & Co. KG is seeking an experienced Verification Engineer III (Test Engineer III) to lead verification activities for advanced medical imaging devices.

You will develop verification strategies, build test infrastructure, and collaborate with cross-functional teams to evaluate complex optical, electrical, and mechanical systems. Ideal candidates bring 6+ years in design and systems verification, familiarity with regulatory standards, and strong leadership to guide projects from

Formación

• Bachelor's degree in Electrical Engineering or related field.
• 6+ years of experience in design and systems verification.
• Experience verifying complex devices and multidisciplinary hardware.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 9001.
• Familiarity with V-model, Agile, or Lean development.
• Experience with DOORS, SAP or LabVIEW tools.

Responsabilidades

• Lead design and systems verification activities for complex medical imaging devices and systems, ensuring compliance with product specifications and regulatory requirements.
• Develop comprehensive verification test plans, protocols, procedures, coverage reports, and technical documentation.
• Design, develop, and implement electrical, optical, and mechanical test fixtures to evaluate system performance and image quality.
• Execute verification procedures, analyze test data, identify failures, and document findings in detailed technical reports.
• Collaborate with Systems, Design, and Project Engineers to establish testable product requirements.
• Conduct characterization studies and troubleshooting to address quality, reliability, and manufacturability challenges.
• Develop sample-size analyses and verification strategies to support product development.
• Identify, document, track, and investigate issues discovered during testing and support root cause analysis.
• Lead verification activities on assigned projects and communicate status, risks, and schedules.
• Review verification procedures and reports prepared by other engineers.
• Mentor and train engineers on verification methodologies and best practices.
• Evaluate testing equipment and collaborate with vendors to support verification activities.
• Support regulatory submissions, including FDA 510(k), by providing verification evidence and technical reports.
• Assist with investigations of product returns and field issues, developing tests to verify proposed resolutions.
• Identify opportunities to improve verification processes and overall product quality.

Conocimientos

Verification planning

Test execution

Root cause analysis

Cross-functional collaboration

Educación

Bachelor's degree in Electrical Engineering

Herramientas

DOORS

LabVIEW

MATLAB

SAP

Descripción del empleo

KARL STORZ SE & Co. KG is seeking an experienced Verification Engineer III (Test Engineer III) to lead verification activities for advanced medical imaging devices.

You will develop verification strategies, build test infrastructure, and collaborate with cross-functional teams to evaluate complex optical, electrical, and mechanical systems. Ideal candidates bring 6+ years in design and systems verification, familiarity with regulatory standards, and strong leadership to guide projects from