Test Engineer III

Karl Storz Endoscopy; Goleta (CA); Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

KARL STORZ is seeking a Verification Engineer III to lead design verification for advanced medical imaging devices, ensuring performance, quality, safety, and regulatory compliance. You will develop verification strategies, build test infrastructure, and collaborate with cross‑functional teams to evaluate optical, electrical, and mechanical systems throughout the product lifecycle.

This hands‑on role requires strong problem solving, ownership of verification activities, and mentoring of junior

Formación

• Bachelor's degree in a technical field and relevant work experience.
• 6+ years in design verification and systems verification.
• Experience verifying complex devices and integrated systems.
• Strong understanding of verification planning and risk assessment.
• Familiarity with regulatory quality systems (FDA 21 CFR Part 820, ISO 13485, ISO 9001).

Responsabilidades

• Lead design and systems verification activities for complex medical imaging devices.
• Develop verification test plans, protocols, and coverage reports.
• Design and implement electrical, optical, and mechanical test fixtures.
• Execute verification procedures and document findings in technical reports.
• Collaborate with Systems, Design, and Project Engineers on requirements.
• Conduct characterization studies and troubleshoot quality issues.
• Develop sample-size analyses and verification strategies for product development.
• Identify, track, and investigate issues discovered during testing.
• Serve as lead verification engineer on assigned projects and mentor engineers.
• Review verification documents prepared by others.
• Support regulatory submissions with verification evidence.

Conocimientos

Verification planning

Requirements management

Root cause analysis

Troubleshooting

Cross-functional collaboration

Communication

Mentoring

Test data analysis

Educación

Bachelor's degree in Electrical Engineering / Electrical & Computer Engineering / Computer Science

Master's degree or PhD (or MBA)

Herramientas

DOORS

PTC

Polarion

SAP

MATLAB

LabVIEW

Descripción del empleo

About KARL STORZ

KARL STORZ is a global leader in medical technology, specializing in innovative endoscopy, imaging, and surgical solutions. Our mission is to advance healthcare through cutting-edge technology, precision engineering, and a commitment to quality.

At KARL STORZ, you'll have the opportunity to collaborate with talented professionals, contribute to meaningful innovations, and help develop technologies that support healthcare professionals and improve patient outcomes.

About the Role

KARL STORZ is seeking an experienced Verification Engineer III (Test Engineer III) to lead and execute design verification activities for our advanced medical imaging devices and systems.

In this role, you'll play a critical part in ensuring our products meet rigorous performance, quality, safety, and regulatory requirements. You'll develop and execute comprehensive verification strategies, design sophisticated test infrastructure, and collaborate with cross-functional engineering teams to evaluate complex optical, electrical, and mechanical systems.

This is an opportunity for a technically strong engineer who enjoys hands-on testing, complex problem-solving, and taking ownership of verification efforts throughout the product development lifecycle.

What You'll Do

• 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 and infrastructure to evaluate system performance and image quality.

• Execute verification procedures, analyze test data, identify failures, and document findings in detailed technical reports.

• Collaborate closely with Systems, Design, and Project Engineers to establish clear, measurable, and testable product requirements.

• Conduct characterization studies and troubleshooting activities to address product quality, reliability, manufacturability, and performance challenges.

• Develop sample-size analyses, design change assessments, and verification strategies to support product development.

• Identify, document, track, and investigate issues discovered during testing, supporting root cause analysis and corrective actions.

• Serve as the lead verification engineer on assigned projects, providing technical guidance and communicating project status, risks, and schedules.

• Review verification procedures, test reports, and technical documentation prepared by other engineers.

• Mentor and train engineers on verification methodologies, test procedures, and best practices.

• Evaluate testing equipment, identify infrastructure needs, and collaborate with vendors to support verification activities.

• Support regulatory submissions, including FDA 510(k) documentation, 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, testing methodologies, and overall product quality.

What You Bring

• Bachelor's degree in Electrical Engineering, Electrical and Computer Engineering, Computer Science, or a related technical discipline.

• 6+ years of experience in design verification and systems verification within a complex product development environment.

• Demonstrated experience verifying complex devices, integrated systems, and multidisciplinary hardware products.

• Strong understanding of verification planning, requirements management, risk assessment, and test execution.

• Experience developing and executing detailed test procedures, analyzing results, and preparing technical verification reports.

• Familiarity with requirements management tools such as DOORS, PTC, Polarion, or similar platforms.

• Knowledge of regulated industry quality systems and standards, including FDA 21 CFR Part 820, ISO 13485, and ISO 9001.

• Experience with product development methodologies such as the V-model, Agile, or Lean.

• Familiarity with environmental testing methodologies and associated equipment.

• Experience using SAP and related information and reporting systems.

• Strong analytical, technical troubleshooting, and root cause analysis capabilities.

• Excellent written and verbal communication skills, including the ability to present technical findings to engineering teams and stakeholders.

• Ability to collaborate effectively across multidisciplinary engineering teams and manage competing priorities.

What Will Make You Successful

• Advanced Verification Experience: 8+ years of systems verification experience within a technically challenging product development environment.

• Advanced Education: Master's degree or PhD in an engineering discipline, or an MBA.

• Technical Versatility: Familiarity with systems engineering, cybersecurity, usability engineering, and complex integrated product architectures.

• Test Automation: Experience with MATLAB, LabVIEW, or similar programming and automation tools used for test development and data collection.

• Technical Leadership: Ability to lead verification activities, mentor engineers, review technical documentation, and provide guidance on complex testing challenges.

• Cross-Functional Collaboration: Experience working with multidisciplinary teams and international engineering organizations.

• Continuous Improvement: A proactive approach to developing new testing methodologies, improving verification efficiency, and strengthening product quality.

• Sound Judgment: Strong decision-making skills, attention to detail, and the ability to independently resolve complex technical challenges.

Why KARL STORZ?

At KARL STORZ, your work contributes directly to the development of medical technologies used by healthcare professionals around the world.

You'll have the opportunity to:

• Work on innovative medical imaging technologies and complex engineering systems.

• Collaborate with experienced engineering professionals across multiple technical disciplines.

• Take ownership of meaningful verification projects from planning through execution.

• Contribute to product quality, patient safety, and regulatory compliance.

• Develop your technical expertise while mentoring and supporting fellow engineers.

• Be part of a global organization committed to innovation, collaboration, and continuous improvement.

Additional Requirements

• Ability to lift testing equipment weighing up to approximately 30 pounds.

• Ability to travel occasionally to other KARL STORZ development facilities, including international locations.

• Ability to work effectively in a technical environment requiring sustained concentration, flexibility, and attention to detail.

• Regular attendance and adherence to company safety and quality procedures.

Join KARL STORZ and help shape the future of medical technology through engineering excellence, innovation, and quality.