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Systems Engineering Architect

Job Description SummaryReporting to the Director of Systems Engineering for BD's Diagnostic Systems business in Sparks, Maryland, the successful candidate will lead a cross-discipline effort to define and deliver innovative, customer centric diagnostic solutions to the market.
This individual will be responsible for development of requirements to ensure adequate system level performance for instrumented diagnostic systems, and should have experience with in vitro diagnostic development, electromechanical systems, assay chemistries, automation technologies, and clinical microbiology. The candidate should have the ability to apply this broad knowledge base to address issues from technology development to concept development to product commercialization and launch. He/she should have the technical skill and domain knowledge to identify technical risk, challenge design decisions, and bridge the gap between functional elements of the product development process.
Job Description
Duties and Responsibilities
Responsible for steering the development of next-generation microbiology diagnostic instrumentation by influencing the contents, cohesion and direction of multiple parallel R&D projects feeding into the final platform. Thought leader for why and how the components of a complex solution should work together to achieve customer desired outcomes.
Responsible for the creation and maintenance of product requirements and high-level design specifications including plans for the integration of modules/ components into a complete system.
Participates as a Product Owner for System Development
Translates customer needs obtained through VOC and ethnography studies into product requirements
Contributes to product conceptualization and develops work plans to reduce concepts to design
Provides technical leadership and direction to the systems engineering team as well as other functional groups (assay/consumable development and hardware/software/test engineering)
Identifies issues and risks and proactively develops contingency plans to address
Develops and maintains an understanding of the full breadth of related technologies available across clinical and non-clinical industries, and leverages this information to ensure development of best-in-class solutions
Works directly with Program Manager and Core Team Leader to address business stakeholder requirements and develop communication packages for cross functional reviews and business updates.
Brings clarity as to how well our systems solution set aligns with overall business objectives and customer needs
Qualifications
Knowledge and Skills
Experience in the development of clinical laboratory and/ or industrial microbiology instrumentation
Experience with systems engineering approaches to in vitro diagnostic development
Experience with requirement and specification management
Knowledge of regulatory requirements following IVD directives (ISO 13485, ISO 14971)
Demonstrated ability to work independently and manage complex, high-visibility projects
Excellent written and oral communication and interpersonal skills
Experience leading project and/ or product development teams, and experience with project management methodologies and tools
Education and Experience
A B.S. or M.S in Mechanical, Electrical, or Biomedical Engineering or closely related discipline is preferred.
Minimum of twelve years relevant experience desired
Minimum 4 years of experience in system architecting roles desired
Minimum of 5 years of experience supervising people and/or leading engineering project teams preferred
Primary Work LocationUSA MD - Baltimore
Additional Locations
Work Shift



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