Test Engineer III

TITLE: Test Engineer III (Job Code: TC1024)

DUTIES:
Under minimum supervision, write test plans and test procedures for the purposes of design verification, run test procedures written by self and others, report test results to project leads, and track issues found during testing. Provide input on the design of electrical, optical, and mechanical test fixtures for measuring opto-mechanical parameters according to ISO standards (including the ISO 8600 series, ISO 15076-1, ISO 12233:2024, ISO 17850:2015, and ISO 15739) and YY China standards (including YY/T 1587, YY 0068.1, YY/T 0068.2, and YY/T 1028). Review product specifications in order to ensure they are comprehensive and testable. With Project Engineers, devise and execute tests to assist in resolving design issues as they relate to product quality, manufacturability, reliability, efficacy, and regulatory compliance. Automate image analysis calculations in MATLAB and automate tests using the KARL STORZ proprietary test automation framework. Assist with troubleshooting of product returns and issues found in the field and recommend test procedures to verify the resolution of field issues and returns. Train other test engineers on test procedures and DQA protocols. Lead verification efforts, including, providing leadership and support to testers in the execution of test plans and procedures; reviewing and tracking issues reported by testers, providing a single point of contact on issues found during testing; working to bring clarity and definition to reported product failures and working to eliminate duplicates and non-issues before reporting to management; and reviewing test procedures and test scripts submitted by others in support of assigned test efforts.

REQUIREMENTS:
Bachelor’s degree (or foreign equivalent) in Computer Engineering, Electronics Technology/Engineering, or related field plus 6 years of experience in the offered position or related position; or Master’s degree (or foreign equivalent) in Computer Engineering, Electronics Technology/Engineering, or related field plus 3 years of experience in the offered position or related position.

SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time”. Required expertise/knowledge includes:

• Experience designing and running complex tests to verify system imaging performance parameters to ensure accuracy and reliability.
• Experience with test validation, including developing validation plans and design Guage R&Rs.
• Knowledge of medical device quality system regulations and standards (MDR, U.S. FDA Quality System Regulation 21CFR Part 820, the ISO 8600 series, ISO 15076-1, ISO 12233:2024, ISO 17850:2015, and ISO 15739, YY/T 1587, YY 0068.1, YY/T 0068.2, and YY/T 1028) to ensure compliance in testing and documentation.
• Experience with test plans and reports requirements for FDA medical device registrations (510k's and Premarket Approvals (PMAs)).
• Technical writing skills for writing clear, accurate and thorough issue reports, test cases, and test results reports.
• Expert in MATLAB including the Image Processing toolbox; expert in a high level programming language/software (C#) for automating testing and data collection; expert in version control using Git.
• Experience in conducting environmental reliability testing using temperature and humidity chambers and accelerating life testing and related equipment, including Thermotron chambers, to assess product performance under varying conditions.
• Experience with common electrical engineering test equipment, including oscilloscopes, multimeters, and related equipment for system evaluation and troubleshooting.
• Experience with common visualization test equipment including spectroradiometers, colorimeters, light meters, video signal generators, integrating spheres and related equipment to analyze imaging system performance.
• Mechanical design skills using Solidworks or a similar authoring tool for the purpose of designing test fixtures to support system verification and testing.
• Foundation in core system performance standards for medical video endoscopes (including ISO 8600-n) to conduct imaging system evaluations and ensure compliance with regulatory requirements.

OTHER: Job Site: Charlton, MA. 40 hours/week; Salary: $126,859 per year. If offered employment must have legal right to work in U.S. EOE.

CONTACT: Karl Storz Endovision Inc., Apply to: [email protected] (Reference Job Code: TC1024).