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Prodigy Lead Systems Engineer

Company: Prodigy Search Group
Location: Irvine
Posted on: April 4, 2021

Job Description:

Our client is a close-knit, collaborative, biotechnology team, guided by a mission to improve lives by making the impossible possible through innovation. They are now developing life-saving detection technologies to help users manage blood glucose levels. We are searching for a Lead Systems Engineer with interdisciplinary experience in medical technology. The Lead Systems Engineer is responsible for managing R&D new product development across all stages of engineering development including system architecture, requirements definition with marketing, concept, prototyping, design, verification and validation, production and support. We are looking for a talented, hands-on engineering leader who can not only participate technically but also ensure that all requirements are understood and integrated into their products. Primary Duties & Responsibilities: --- Will be a technical leader across all R&D Engineering functions. --- Collaborate with an inter-disciplinary engineering team to develop effective solutions to challenging problems. --- Develop and maintain design inputs documentation including user needs, system-level requirements, product specifications, traceability matrices, and test specifications. --- Knowledge and understanding of laboratory terminology, good laboratory practices (cGLP) and good manufacturing practices (cGMP) --- Define and execute non-functional requirements, such as manufacturability, serviceability, cost, reliability. --- Create a top-level system architecture including interface, HW/SW partitioning and processing requirements. This will be achieved by close interactions across functional teams. --- Work cross-functionally with engineering teams, quality, manufacturing, validation, project risk management, usability, human factors, and regulatory standards compliance. --- Define and execute the system integration plan. --- Mentor and coach junior-level engineers to achieve engineering excellence. Qualifications and Experience: --- BS in Electrical Engineering, Software Engineering, Biochemistry, Polymer Chemistry, or Process Systems Engineering. --- MS or PhD desired. --- 10+ years Engineering new product development with emphasis on manufacturability and quality in the medical device industry. --- 5+ years of experience in an Engineering management role. --- In depth technical expertise in analyzing, developing, integrating and troubleshooting low power software-driven electro-mechanical systems including analog electronics. Contact: Terry McCarthy (949) 716-3524 2 --- Experience with mobile and cloud software development in a regulated environment. --- Knowledge of polymer coatings, material characterization and electrochemical systems. --- Medical device experience with Class II and Class III devices. --- Ability to lead a team as well as contribute individually in a fast-paced, changing environment. --- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Keywords: Prodigy Search Group, Irvine , Prodigy Lead Systems Engineer, Other , Irvine, California

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