Principal Systems Engineer

Resuscitation, ZOLLMED.com 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 Resuscitation division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. With customers in more than 140 countries, we are constantly expanding our reach as well as our product offerings. Physicians, nurses, emergency responders, public safety officers, and many others trust us to provide top-quality, lifesaving products and exceptional customer service. And because we know that ZOLL employees deliver, we are proud to invest in their success. We offer competitive compensation aligned with the industry and a comprehensive benefits package. 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! Job Summary The Principal Systems Engineer is a highly experienced, cross-functionally skilled technical leader (Electrical/Mechanical/Software) responsible for the system-level architecture/design, implementation, and verification of complex systems (e.g. defibrillators, patient monitors) Essential Functions Collaborates with New Product Planning/Product Management and others (Medical Affairs, Regulatory Affairs, Human Factors, etc.) to identify and prioritize patient and/or stakeholders needs for the product throughout the early development life cycle (from concept through design output). Activities may include customer and stakeholder interviews, use case identification and development, and feature set prioritization. Manages trade-offs and compromises within multi-discipline design teams. Establishes performance, interface, safety, and cost-specifications for each subsystem within selected architecture in consultation with functional design leaders. Drives activities to generate system-level engineering requirements from market requirements/needs. 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 interface requirements. Leads the system architecture definition and collaborates with engineering development team to refine the system architecture. Establishes performance, interface, safety, and cost specifications for each sub-system within the selected architecture in consultation with Program Manager and functional design leaders. Drives Engineering team to identify technical investigations to address architectural and requirement unknowns and technical risk areas. Under the auspices of the Program Manager, leads efforts to allocate system functionality among electronic/software/mechanical subsystems, makes hardware/software/mechanical trade-off decisions, cost/time/performance trade-off decisions, and safety decisions necessary to meet the product’s clinical performance, reliability, manufacturability, 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. Assists Engineering team with test case generation pertaining to system-level and detailed-level requirements, as needed. Collaborates with Regulatory Risk Manager to help Engineering team assess product risk. Collaborates with engineering managers and technical program managers to identify resource needs. Required/Preferred Education and Experience B.S. degree in Engineering, required, or M.S. degree in Engineering, preferred. 15 years' experience developing electronic hardware and embedded software systems/subsystems for complex, real time measuring systems. Knowledge of medical device development under FDA and European Community regulations preferred. Knowledge, Skills and Abilities Extensive knowledge and experience in the system-level design and development of multi-processor based medical instruments, strongly preferred. Demonstrated ability to plan, direct, and conduct engineering research and development activities. 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 patient treatment systems. Knowledge of ISO 14971 and IEC 60601-1, highly desired. Strong conflict resolution, analytical and decision-making skills. Strong verbal and written communication skills. 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' 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.