Verification and Validation Engineer - Medical Devices

Company: Affinity Executive Search
Location: Cincinnati
Posted on: November 24, 2020

Job Description:

Global medical devices company seeks a Verification and Validation Engineer to join the companys R&D team at its product development center in Cincinnati., The Verification and Validation Engineer is responsible for planning and organizing verification and validation programs, and leading usability engineering processes. He or she will also be in charge of defining verification and validation strategy as well as continuously improving V&V methods and tools in order to optimize testing activities and improve testing coverage. Requirements for the Verification and Validation Engineer: * Bachelors degree in engineering or relevant discipline * 7+ years of experience in product development in a highly regulated industry * 3+ years of experience in the development of medical devices * Experience in driving Design Verification and Validation activities. * A depth of experience designing and setting automated test benches. * Working experience with automated test bench GAMP5 validation. * Experience with automated test bench programming (i.e. Python, Labview) * Strong knowledge of sample size determination principles. * Familiarity with a statistical software tool is a plus (i.e. Minitab). * Knowledge of Six Sigma and Value Stream Mapping techniques. * An understanding of stress testing, including accelerated aging and transit testing. * Expert understanding of design control processes as defined per ISO13485 and FDA 21 CFR Part 820. * Knowledge of usability standard applied to medical devices IEC 62366. * Familiarity with risk management ISO 14971. * The ability to work in a highly matrixed international environment in different time zones. * Familiarity with requirements and changes management systems * Strong working experience with Microsoft Office products Word, Excel, and Power Point * Strong communications skills, oral, written and electronic * The ability to manage complex competing projects and priorities Responsibilities: * Review customer, product and subsystem requirements to ensure consistency, coverage, traceability and testability. * Conduct impact analysis and evaluate which compliance evidences need to be reassessed or provided during design change. * Define verification and validation strategy that ensuring full requirement coverage, defect detectability, optimize time and resources. * Write verification and validation protocols * Compile data and write test reports. * Drive V&V activities and functionally lead testing team including engineers and technicians. * Establish testing planning and ensuring availability of resources, tools and test samples. * Develop automation of tests with a risk-based approach to accelerate testing, optimize coverage and repeatability. * Lead validation and summative usability testing: define strategy & protocols, enroll end users in the testing sessions, conduct testing with end users, collect and formalize relevant feedback. * Organize and lead formative usability testing for NPI projects. * Manage usability and human factors engineering files.

Keywords: Affinity Executive Search, Cincinnati , Verification and Validation Engineer - Medical Devices, Engineering , Cincinnati, Ohio