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Consultant Medical Device Systems Engineer Biotechnology

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Owings Mills, MD

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Job Description
Our client is developing an IVD biotechnology device focused around clinical cytogenetics and is in need of a Consultant, Medical Device Scientist / Systems Engineer for a long term, multi-year consulting engagement. Please review the job description below and apply if your experience aligns.\r\r Summary Description:\r \r Lead the product development science / systems engineering activities for the development, validation, production and support of an IVD device. Participate in the development process through definition of proper and testable product requirements, conduct design reviews, oversee verification and validation activities. Deliver analysis, test results and reports that support design control compliance with regulatory guidance.\r \r \r Job duties:\r \r Responsible for leading and performing systems engineering activities during product development, including formal design verification and validation.\r Ensure product requirements are defined and are testable\r Develop work instructions and templates to support the product development process, particularly regarding design verification and validation.\r Plan, oversee and execute the verification and validation activities in the project/system, including initiation, test design, coordination, synchronization, review and integration of the technical work.\r Support and interact with other teams for verification, integration, validation and post validation. Coordinate verification and validation activities over multiple locations.\r Review and approve executed test results to confirm test results provide proper objective evidence to meet requirements.\r Recommend design changes that may result in reduced cost or improved quality.\r \r \r\r

Job Requirements
\r Required Skills:\r \r Demonstrated ability to lead project activities and drive actions to closure\r Knowledge of ISO and FDA regulations, specifically 21 CFR 820.30 and related regulations\r Verification and Validation experience with FDA-cleared or approved IVDDs\r Knowledge of FDA 510(k)/PMA/De Novo process strongly preferred.\r Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint.\r \r \r Required Qualifications:\r \r Bachelor’s degree in related field\r 5 years Verification and Validation experience in IVD industry while working on an FDA cleared or approved device\r 7-10 years of overall experience in a fast-paced environment, preferably in the medical device or another regulated industry, with 2-3 years of successfully leading others.\r \r \r Additional Requirements:\r \r Ability to interact with colleagues in a team environment\r Proficient organizational, record keeping and communication skills (oral and written), with excellent presentation technique\r Strong work ethic to generate high quality work under tight deadlines\r Demonstrated leadership and self-motivation.  Ability to motivate and guide others to meet objectives.\r \r \r

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