As the Lead Systems Engineer, you will be manage R&D of 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.
Seeking for a talented, hands-on engineering leader who is able to participate technically to ensure all requirements are understood and integrated into our products. This is NOT a remote opportunity.
What You Will Be Doing
The Lead Systems Engineer will be a technical leader across all R&D Engineering functions.
Collaborate with an interdisciplinary engineering team to develop effective solutions to challenging problems.
Develop/maintain design inputs documentation; user needs, system-level requirements, product specifications, traceability matrices, and test specifications.
Knowledge/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, Hardware /Software partitioning and processing requirements.
Work cross-functionally with engineering teams, quality, manufacturing, validation, risk management, usability, human factors, and regulatory compliance.
Define and execute the system integration plan.
Mentor and coach junior-level engineers for achieving engineering excellence
What You Need for this Position
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.
Ability to lead a team as well as contribute individually in a fast-paced, changing environment.
Medical device experience with Class II and Class III devices.
In depth technical expertise with analyzing, developing, integrating, troubleshooting low power software-driven electro-mechanical systems including analog electronics.
Experience with mobile and cloud software development in a regulated environment.
Knowledge of polymer coatings, material characterization and electrochemical systems.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
For your hard work and dedication, earn a generous salary plus bonus and stock option along with a competitive benefits package including 401k plus the opportunity to advance your career path. So, if you are a Lead Systems Engineer with the required experience, please apply today!
Applicants must be authorized to work in the U.S.
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