Works with Project/Program management to help establish and refine system level requirements for assigned new and enhanced products.
Member of development team in translating system level requirements into product architecture and system level design including partitioning functionality into sub-systems, often creating specifications for each sub-system and documenting the interface requirements among the sub-systems.
Ensures that new product architecture meets system level requirements, is appropriately featured, robust, and adaptable enough to support product lifecycle plans and objectives.
Helps establish performance, interface, safety, and cost specifications for each sub-system within the selected architecture in consultation with the functional design leaders. Contributes to the system level risk management activities associated with assigned programs.
Works with Program Manager and others to allocate system functionality among electronic/software/mechanical subsystems, recommends hardware/software/mechanical trade-offs, cost/time/performance trade-offs, and safety decisions necessary to meet the product's clinical performance, reliability, manufacturability/serviceability, regulatory, and business objectives.
Contributes 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.
Contributes to 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 new and existing products.
Researches and documents the relationships between clinical requirements, architectural decisions, performance requirements, and product evolution plans
As member of the System Engineering team, provides input to engineering teams regarding system engineering principles and system level requirements of ZOLL products.
Participates in decision making processes that involve changes to the system level design of existing products.
Ability to contribute in translating high level product requirements into system and sub- system level specifications and designs.
Demonstrated success as engineering team member in the architecture, system level design, integration and verification of portable, battery operated, multiprocessor-based measuring and/or patient treatment systems.
Knowledge and experience in many of the following: 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.
Some knowledge of mechanical engineering issues and processes associated with electronics packaging, small moving mechanisms, molding and machining processes is helpful.
Ability to independently analyze and evaluate at least two of the following three areas by drawing up technical education and experience: electronic circuitry, software, and mechanical designs (using drawings, schematics, and/or source code).
Some understanding of product development and engineering project management processes.
Some experience with and sensitivity to human factors issues associated with the use of medical devices is helpful.
Some knowledge and experience developing products under FDA and European Community medical device regulations and standards is helpful.
Good verbal and written communications skills.
Demonstrated success in technical decision making in a matrix environment.
Required/Preferred Education and Experience:
Bachelor's degree in Engineering including training and experience in three of the following: systems, electronics, software, and mechanical engineering. Master's degree in engineering is a plus.
7+ years' experience developing electronic hardware and embedded software systems subsystems for complex, real-time measuring instruments.
Some knowledge and experience in the system level design and development of multiprocessor-based signal acquisition, processing electronics, and embedded software systems. Experience with medical instruments and biomedical signal acquisition helpful.
Past experience with ventilators or aspirators is desired