Sr. Systems Engineer- Medical Devices

ob Summary:

Experienced, cross-functionally skilled engineer (electrical/software/mechanical) responsible for Systems Engineering efforts associated with company's product lines (e.g. defibrillators, patient monitors, ventilators). Primary responsibilities include assisting with system level architecture/design and contributing to the implementation and verification of complex defibrillator/patient monitor systems in a matrix setting.

Essential Functions:

• 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 products.

• Participates in decision making processes that involve changes to the system level design of existing products.

Skills Requirements:

• 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