Engineering Technician 4
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The Verification and Validation (V&V) Specialist will be engaged in verifying custom designed, software-driven production test equipment deployed into manufacturing sites to assess the performance of electro-mechanical assemblies. V&V Specialists will also verify the functional correctness of production support software systems. All V&V activities are to be conducted according to FDA requirements and internal quality standards. This position provides support to the New Product Development Technical Operations team to meet project deliverables in the completion of development testing. Project deliverables include producing verification and/or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations. The V&V specialist ensures V&V procedures are aligned to internal and regulatory process requirements.
* Works closely with all engineering disciplines including R&D Systems Engineering, Project Management, and Quality personnel to verify and validate products
* Define and develop test systems in the lab. Ensure that all test systems and equipment are appropriate, maintained, and calibrated.
* Work with project teams to create, review, and approve verification and validation deliverables
* Perform verification and validation testing.
* Review and analyze test data and record pass/fail results and conclusions
* Track and report on progress toward completion of verification and validation
* Summarize the verification and validation performed, the data reviewed, and conclusions reached
* Review test input requirements for completeness, correctness, clarity and testability by providing input, creating or revising V&V related procedures.
* The V&V Specialist will also identify and implement V&V process efficiencies and establish best practices for our internal functional expertise.
* B.S. degree in Computer Science, Engineering or other related discipline
* 3+ years of experience in design verification or validation, emphasis on software and hardware testing
* Experience with product development per FDA design control and ISO 13485 desired
* Experience creating verification and validation plans, protocols, and reports
* Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools
* Knowledgeable in testing methods, strategies, and best practices for release of software driven, electro-mechanical assemblies
* Understanding of engineering best practices and test methodologies
* Demonstrated capability to solve technical problems
* Experience and knowledge of various measurement and test devices for use in testing electro-mechanical assemblies
* Familiarity with specifying software test steps and control flows to drive software development of test devices
* Experience with software development preferred, numerical analysis and algorithmic functions
* Familiarity with electronic schematics
* Experience in creating and executing validation protocols for process and test equipment in a FDA regulated industry
* Can work independently in a fast paced new product development environment.
* Experienced with running test case design reviews to establish effective approach
* Medical equipment or other equipment experience involving complex, multi-component systems desired
* Familiarity and troubleshooting skills working on electronics, harnesses, sensors, data acquisition boards and devices, fixtures, motors, controllers, pumps, valves, etc
* Preferred software language experience: Labview, LV projects and libraries, Active X and .NET components, SQL, along with one or more scripting languages such as VBScript, Jscript, Perl, Python or TCL
* Experience with automation tools for testing applications (Labview, Matlab)
* Familiarity with databases, XML, and test automation scripting and source code control systems
* Experience and knowledge of various measurement and test devices (such as NI-DAQ) for use in testing electro-mechanical assemblies.
* Familiar with engineering process improvement methodologies
* Manage multiple tasks and priorities simultaneously and adapt to changes in program priorities
* Excellent communication and interpersonal skills
* Technically communicate internally and with external clients
* Keep up to date with new technologies as applicable to projects
* Write scripts and develop other infrastructure for automated software test fixtures
* Test experience in medical or military products is highly desirable
* Experience with Test Method Validations (TMV) and Gauge R&R evaluations
* Highly self-motivated, self-directed, team orientated, and exceptionally attentive to detail.
* Demonstrated ability to effectively engage, influence, set priorities and manage the expectations of cross-functional teams
* Proficient in current industry software and Microsoft Office