Principal Systems Engineer - Medical Devices
About The Position
The Principal Systems Engineer is a highly experienced, cross-functionally skilled technical leader responsible for system-level architecture, design, implementation, and verification of complex defibrillator and patient-monitor systems in a matrix environment. The role works with project and program management to establish system requirements, leads development teams in translating requirements into system architecture and subsystem specifications, and guides technical decisions across electronic, software, and mechanical disciplines. The engineer leads system design refinement, subsystem integration, and verification to ensure products meet clinical performance, reliability, manufacturability, serviceability, regulatory, safety, and business objectives. The role also documents system designs and interfaces, researches links between clinical requirements and product architecture, and advises engineering teams on systems engineering principles and existing product design changes.
Requirements
- Advanced degree in Engineering, including training and experience in systems, electronics, software, and mechanical engineering.
- 15+ years of experience developing electronic hardware and embedded software systems or subsystems for complex, real-time measuring instruments.
- 10+ years of experience as a Systems Engineer leading architectural design and systems engineering of complex, real-time medical measuring instruments.
- 7+ years of experience leading systems engineering of multiprocessor-based systems incorporating analog/digital electronics and embedded real-time software.
- Project management experience and training.
- Extensive knowledge and experience in system-level design and development of multiprocessor-based medical instruments containing biomedical signal acquisition and processing electronics and embedded software systems.
- Ability to translate high-level product requirements into system- and subsystem-level specifications and designs.
- Demonstrated success leading engineering teams in architecture, system-level design, integration, and verification of portable, battery-operated, multiprocessor-based measuring or patient-treatment systems.
- Working knowledge of 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.
- Ability to independently analyze and evaluate electronic circuitry, software, and mechanical designs using drawings, schematics, source code, technical education, and experience.
- Thorough understanding of product development and engineering project management processes.
- Experience with and sensitivity to human factors issues associated with medical device use.
- Knowledge and experience developing products under FDA and European Community medical device regulations and standards.
- Excellent verbal and written communication skills.
- Demonstrated success in technical decision-making and people management or leadership in a matrix environment.
- Business acumen.
Responsibilities
- Work with project and program management to establish and refine system-level requirements for new and enhanced products.
- Lead development teams in translating system requirements into product architecture and system-level design, including subsystem partitioning, specifications, and interface requirements.
- Ensure product architecture satisfies system requirements and supports product lifecycle plans and objectives.
- Establish performance, interface, safety, and cost specifications for subsystems in consultation with functional design leaders, and contribute to system-level risk management.
- Lead allocation of system functionality among electronic, software, and mechanical subsystems; make trade-off decisions involving hardware, software, mechanics, cost, time, performance, and safety.
- Lead system-level design development and refinement during implementation, identifying and resolving subsystem performance, interface, and cross-functional design issues.
- Lead or oversee subsystem integration and verification testing to ensure subsystem goals and integrated system performance, safety, and cost requirements are met.
- Document system-level design, operating principles, and subsystem interface specifications for assigned new and existing products.
- Research and document relationships among clinical requirements, architectural decisions, performance requirements, and product evolution plans.
- Advise engineering teams on systems engineering principles and system-level requirements for ZOLL products.
- Participate in decisions involving changes to the system-level design of existing products.
Benefits
- Annual bonus in accordance with the company's bonus plan.
- Comprehensive benefits plans; details are available at www.zollbenefits.com.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
