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Principal Systems Engineer

ZOLL Medical Corporation

ZOLL Medical Corporation

Software Engineering
Chelmsford, MA, USA
Posted on Thursday, July 27, 2023
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 responsible for the methodical, disciplined approach to the conception, design, development, and technical management of ZOLL's product realization process. Primarily, the Principal Systems Engineer collaborates with New Product Planning/Product Management to help define the patient's and/or stakeholder's needs. The Principal System Engineer translates those needs into engineering system level requirements and establishes the essential functionality in the early stages of product or service development cycle. Once needs are defined, the Principal Systems Engineer will ensure and lead the major activities of the multi-functional engineering team via ZOLL processes and good engineering practices throughout the product development life cycle, including: system requirements, system architecture, detailed requirements, detailed design/peer reviews, and predictive/analytical methodologies. In addition, the Principal System Engineer will assist the engineering development team through engineering verification/reliability testing, FMECA analysis, and risk management, as needed.

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 and detail-level engineering requirements from market requirements/needs.
  • Drives activities for cross functional approval (including non-R&D depts.) of system level and detailed level engineering requirements.
  • Leads the system architecture definition and collaborates with engineering development team to refine the system architecture.
  • Drives R&D team to identify technical investigations to address architectural and requirement unknowns and technical risk areas.
  • Assists the R&D team with test case generation pertaining to system-level and detailed-level requirements, as needed.
  • Collaborates with Regulatory Risk Manager to help R&D 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 of product development.
  • Medical device, FDA regulatory experience, 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.
  • 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.