Principal Systems Engineer - Medical Devices

Acute Care Technology
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won't just have a job. You'll have a career-and a purpose.

Join our team. It's a great time to be a part of ZOLL!

Due to the on-site requirements of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (San Jose, CA). This role does not offer relocation.
Job Summary

Highly experienced, cross-functionally skilled technical leader (electrical/software/mechanical) responsible for the system level architecture/design, implementation and verification of complex defibrillator/patient monitor systems in a matrix setting.

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 ZOLL products. Actively participates in decision making processes that involve changes to the system level design of existing products.

Required/Preferred Education and Experience

• Advanced degree in Engineering including training and experience in systems, electronics, software and mechanical engineering.
• 15+ years' experience developing electronic hardware and embedded software systems/subsystems for complex, real time measuring instruments.
• 10+ years' experience as a Systems Engineer, leading the architectural design and systems engineering of complex, real time medical measuring instruments
• 7+ years of experience leading the systems engineering of multiprocessor based systems incorporating analog/digital electronics and embedded real time software.
• Project management experience and training.

Knowledge, Skills and Abilities

• 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.
• Business acumen.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

ZOLL Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future.

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

The annual salary for this position is:
$144,400.00 to $21,600.00

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at .

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.