Test Engineer II

From the operating room to surgery centers, and everywhere in between, KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging, to build a more connected, software-enabled operating room.

As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients' lives around the world.

The Design Verification Test Engineer supports the verification and validation of KARL STORZ products to ensure they meet established quality, performance, reliability, and regulatory requirements. Working with minimal supervision, this role develops and executes design verification test plans and procedures, supports engineering troubleshooting and design investigations, and collaborates closely with cross-functional engineering and manufacturing teams.

The ideal candidate brings a strong technical engineering foundation, hands-on testing experience, and the ability to clearly document and communicate test results within a regulated medical device environment.

• Develop comprehensive design verification test plans and test procedures based on product requirements and specifications.

• Execute verification procedures developed by yourself and other engineers, accurately documenting and reporting results.

• Track, investigate, and communicate issues identified during testing to project and engineering teams.

• Review product specifications to ensure requirements are comprehensive, measurable, and testable.

• Partner with Project Engineers to develop and execute testing related to product quality, manufacturability, reliability, efficacy, and regulatory compliance.

• Provide input into the design and development of electrical, optical, and mechanical test fixtures.

• Troubleshoot product returns and field issues and recommend testing methods to verify corrective actions and design resolutions.

• Support environmental testing and the evaluation of test equipment required to perform quality and verification activities.

• Train other Test Engineers on verification procedures and Design Quality Assurance protocols.

• Collaborate with Engineering, Manufacturing Engineering, Engineering Technical Services, vendors, and application engineers to resolve technical issues.

• Perform additional related responsibilities as assigned.

• Bachelor's degree in Electronics Technology, Engineering, or a related technical field with 3-5 years of technical/test engineering experience; or

• Master's degree in Electronics Technology, Engineering, or a related field with 0-3 years of technical/test engineering experience.

• Experience developing and executing engineering test plans and test procedures.

• Strong analytical, troubleshooting, and problem-solving skills.

• Strong technical documentation and report-writing skills.

• Effective written and verbal communication skills.

• Familiarity with environmental testing methods and equipment.

• Experience with automated testing and data collection.

• Familiarity with programming or test automation tools such as MATLAB, LabVIEW, or similar technologies.

• Experience supporting verification activities for products incorporating electrical, optical, and mechanical components.

• Previous experience working within a regulated medical device or similarly regulated engineering environment.

• Knowledge of medical device quality systems and applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 9001.