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Lead Engineer, System

Position Overview:
This role is responsible for systems engineering as a member of a multidisciplinary new product development team. This position will understand and define customer needs; product functionality and performance requirements; product architecture, constraints and trade-offs; design and interface requirements, technical risks of new products being developed. You will provide leadership to the engineering team members on the overall design of the final product while determining what verification is required, including the amount of data required and the methodology for collecting and analyzing the data.
Key Responsibilities:
Extract customer needs and translate into product functional and performance requirements through collaboration with cross functional Marketing, Clinical and User Experience teams
Lead the technical engineering team through the overall design and development of the product
Maintain product requirements throughout project
Develop system architecture for the products, based on technology and platform strategies
Objectively and holistically communicate trade-offs and design options
Document the flow of data through a system
Define subassembly interfaces and allocate subassembly requirements to design teams
Conduct impact analysis for design changes and implement necessary actions
Identify technical problems and provide innovative and creative solutions
Contribute to fault tree analysis and design FMEAs
Ensure requirements are testable and can be verified and validated
Support root cause identification, corrective actions and re-verification/validation of identified product defects
Required Background:
Bachelor's Degree (Mechanical, Electrical, Software Engineering or comparable technical discipline)
10 years of engineering experience
5 years of experience leading technical teams
Demonstrated experience translating customer needs into design requirements and architecture
Demonstrated experience working on new product development projects; experience with regulated industries and FDA Design Controls is preferred
Demonstrated experience making project tradeoff decisions due to constraints and drive action to decisions
Strong organizational and communication skills
Proficient problem-solving skills
Strong interpersonal skills with the ability to work collaboratively with others in a team environment
Working knowledge of systems engineering methodologies

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