Job Title:

Medical Device Engineer 2

Location:

San Diego, CA Duration:

Months Job Description:

We are seeking a Test Method Validation Engineer to support R D laboratory activities focused on the optimization, standardization, and validation of electrochemical test methods for sensor development initiatives. The role will collaborate closely with engineering teams to execute validation activities, perform equipment qualification, analyze test data, troubleshoot test systems, and develop technical documentation.

Responsibilities:

Support optimization and standardization of electrochemical testing methods and laboratory test preparation activities. Develop and execute Test Method Validation Plans, Protocols, Reports, Verification Test Reports, and Equipment Qualification Documents. Perform equipment qualification activities, including equipment assembly, testing, fixture validation, process verification, and electronics testing. Support creation and execution of validation protocols, test procedures, and technical documentation. Execute test scripts and laboratory test procedures. Perform data analysis and provide statistically supported conclusions. Conduct Measurement System Analysis (MSA) and Gage R&R studies to evaluate measurement system performance. Investigate testing issues and troubleshoot test systems to identify sources of measurement variation. Perform basic troubleshooting of laboratory instrumentation, computers, and test equipment. Support laboratory equipment qualification, calibration, and maintenance activities. Prepare technical documentation supporting test method validation and equipment qualification. Manage documentation through formal change control processes for review and approval. Support approval and release of test system documentation through equipment management systems. Gather technical information and data to support troubleshooting and continuous improvement activities.

Required Skills:

Experience with test method validation, verification testing, or equipment qualification. Strong technical writing skills with experience developing test protocols, reports, and technical documentation. Experience with data analysis and statistical evaluation of test results. Knowledge of MSA/Gage R&R studies and measurement system analysis. Hands-on experience troubleshooting laboratory equipment, instrumentation, and test systems. Ability to execute detailed test procedures and maintain accurate documentation. Strong problem-solving skills and attention to detail. Ability to collaborate effectively with engineering and R D teams.

Preferred Qualifications:

Experience in medical device, biotechnology, diagnostics, electronics, or regulated R D environments. Experience with

IQ/OQ/PQ

documentation and validation processes. Familiarity with electrochemical testing, sensor testing, or laboratory test systems. Experience with equipment calibration and qualification management systems. 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Medical Device Engineer 2