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Test Engineer - Wilmington, United States - PCS Technical Services Inc.
Description
Test Engineer
Salary: 80-100k
Reports To: Engineering Management
Summary
Primary responsibilities include support for the Engineering teams in physical testing and report writing to support verification and validation activities.
The Test Engineer will work closely with Engineering project teams to ensure reliable products through functional testing of product.
Essential Duties and Responsibilities
Primary Requirements:
o Responsible to the project team as subject matter expert in verification and validation of medical devices. Lead communication and provide issue escalation support to project teams.
o Responsible for conducting physical, functional tests of products. Must have hands-on mechanical experience and enjoy a shop/lab setting. Manual, mechanical labor will constitute up to 50% of role.
o Develop test plans for medical devices. Regularly generates complex data using spreadsheets, researches the literature as a means to justify testing parameters and evaluate designs.
o Author test reports for medical devices. Regularly analyzes data for statistical evaluations to draw conclusions.
o Coordinate with outside test houses for test scheduling, methods, acceptance criteria, results analyses, and reporting. Attend testing to witness and ensure appropriateness to project team needs.
o Responsible for developing new test methodologies where appropriate to best verify and validate both on-market products and R&D prototypes. Regularly troubleshoot, diagnose, and repair existing test equipment. Design and fabricate fixtures to aid in testing.
o Work with engineering, quality and regulatory to ensure products maintain certification to various standards. Ability to quickly gain an understanding of complex medical device standards; enjoy researching details and minutiae.
o Multiple project track record of test activities accountable to business for program success a plus. NPI experience a plus.
o Exposure to and/or basic engineering understanding of design principles related to electrical assemblies, electro-mechanical/hydraulic devices, motors, control systems, test equipment and data collection, instrumentation and calibration, wiring harnesses, metalworking, machining.
o Exposure and/or basic understanding of medical devices a plus.
o Experience with Solidworks a plus.
o Ability to read and analyze engineering drawings, interpret professional journals, technical procedures, and government standards and regulations.
