Medical Device Systems Engineer

Essential Functions: Works with Project/Program management to establish and refine system level requirements for assigned new and enhanced products. Leads development team in translating system level requirements into product architecture and system level design including partitioning functionality into sub-systems, creating specifications for each sub-system and documenting the interface requirements among the sub-system. Ensures that new product architecture meets system level requirements, is appropriately featured, robust and adaptable enough to support product lifecycle plans and objectives. Establishes performance, interface, safety, and cost specifications for each sub- system within the selected architecture in consultation with the functional design leaders. Contributes significantly to the system level risk management activities associated with assigned programs. Under auspices of the Program Manager, leads efforts to allocate system functionality among electronic/software/mechanical subsystems, make hardware/software/mechanical trade-off decisions, cost/time/performance trade-off and safety decisions necessary to meet the product's clinical performance, reliability, manufacturability/serviceability, regulatory and business objectives. Leads efforts during the product implementation phase to develop and refine the system level design, identify and resolve sub-system performance and interface issues, and resolve cross-functional design issues that have system level impacts. Leads/oversees team efforts during the subsystem integration and verification testing phases to ensure that critical sub-systems meet their individual performance, interface and system integration goals and to ensure that the fully integrated system robustly meets its performance, safety and cost requirements. Responsible for documenting the system level design, operating principles and sub-system interface specifications for his/her assigned new and existing products. Researches and documents the relationships between clinical requirements, architectural decisions, performance requirements and product evolution plans. Provides advice and consultation to engineering teams regarding system engineering principles and system level requirements of products. Actively participates in decision making processes that involve changes to the system level design of existing products.

Skills Requirements: Extensive knowledge and experience in the system level design and development of multi-processor based medical instruments containing biomedical signal acquisition and processing electronics and embedded software systems. Demonstrated ability to translate high level product requirements into system and sub-system level specifications and designs. Demonstrated success leading engineering teams in the architecture, system level design, integration and verification of portable, battery operated, multi-processor based measuring and/or patient treatment systems. Working knowledge and experience with low level analog signal acquisition, digital/microprocessor systems design, power supplies, embedded real time software development, digital signal processing, real time operating systems, Analog/digital control systems, displays, batteries, data storage and wireless communications systems. Working knowledge of mechanical engineering issues and processes associated with electronics packaging, small moving mechanisms, molding, and machining processes. Ability to independently analyze and evaluate electronic circuitry, software and mechanical designs using drawings, schematics, source code, technical education, and experience. Thorough understanding of the product development and engineering project management processes. Experience with and sensitivity to human factors issues associated with the use of medical devices. Knowledge and experience developing products under FDA and European Community medical device regulations and standards. Excellent verbal and written communications skills. Demonstrated success in technical decision making and people management/leadership in a matrix environment. Ability to handle confidential information with discretion and skill. Business acumen. Required/Preferred Education and Experience: Advanced degree in Engineering including training and experience in systems, electronics, software and mechanical engineering.10+ years' experience developing electronic hardware and embedded software systems/subsystems for complex, real time measuring instruments.7+ years' experience as a Systems Engineer, leading the architectural design and systems engineering of complex, real time medical measuring instruments. Knowledge of fluid mechanics and/or past experience with ventilators/aspirators is required. Project management experience and training.