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