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 Acute Care Technology division of ZOLL 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.

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

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As Director, Systems Engineering, you will lead the system engineering activities across ZOLL's Resuscitation Research and Development (R&D) organization. You will build a system engineering team that will include multi-disciplinary engineers. The Director will establish best practices and processes that apply consistent system engineering principles across a diverse set of products and programs within the R&D organization. You and your team will be responsible for requirements management from user needs to verification and validation, system architecture design (including tradeoff decisions), and regulatory and standards compliance for the design and maintenance of complex electromechanical software-controlled medical devices (e.g., external defibrillators, patient monitors, and ventilators).

This role will be based in our Chelmsford, MA headquarters and will report to the Vice President of Advanced Development.

Essential Functions

• Establish a systems engineering function, team, and process that is aligned with the company’s goals and objectives.
• Manage the newly established systems engineering team; providing guidance, coaching, and feedback, and ensuring high performance and engagement.
• Collaborate with global product management and R&D program management and engineering functions to establish and refine system level requirements for new and enhanced products.
• Oversee requirements management and design architectures for products throughout their lifecycle, from concept to launch and sustaining engineering, and ensuring compliance with regulatory standards and customer requirements.
• Guide the requirements management and system architecture definition processes, ensuring that product systems meet user, functional, performance, safety, and reliability specifications and are also adaptable to support product lifecycle plans and objectives.
• Lead the team in translating system level requirements into product architecture and system level design including partitioning product functionality into sub-systems, creating specifications for each sub-system and documenting the interface requirements among sub-systems.
• Collaborate with cross-functional teams, including regulatory, clinical, quality and operations.
• Lead development of and maintaining best practices, procedures and processes, and tools for systems engineering, such as requirements management, architecture design, risk management, verification and validation, and traceability.
• Lead continuous improvement and innovation in the systems engineering domain and staying current on the latest technologies and trends in the medical device industry.

Knowledge, Skills and Abilities

• Proven leadership and management skills, with the ability to inspire, motivate, and develop a diverse and high-performing multi-disciplinary team.
• Demonstrated success leading engineering teams in system requirements definition, architecture and system level design, integration and verification of complex electromechanical software-controlled medical devices.
• Demonstrated ability to translate high level user and product requirements into system and sub-system level specifications and designs.
• Deep technical understanding of system engineering principles (e.g., functional and structural decomposition, product budgets, formalized decision making, set-based design, and root cause analysis).
• Multi-disciplinary working knowledge of integrated electrical, software (including programming and algorithms), and mechanical systems.
• Extensive knowledge and experience in the system level design and development of multiprocessor based medical devices.
• Working knowledge and experience with electromechanical software-controlled medical device systems, such as microprocessor systems design, low-level analog design, power and heat management, embedded software development, DSP, RTOS, control systems (e.g., pneumatic), displays, batteries, data storage, IPx-rated enclosure design, wireless communications systems, and DFx.
• Working knowledge of usability and human factors engineering and cybersecurity for medical devices.
• Strong understanding of medical device product development.
• Strong technical skills and knowledge in systems engineering methodologies, tools, and medical device standards, including ISO 13485, IEC 60601, ISO 14971, IEC 62304, ISO 80601, AAMI/ANSI HE75 (human factors), and ANSI/AAMI SW96:2023 (cybersecurity).
• Excellent communication (written and oral) and interpersonal skills with the ability to communicate effectively with internal and external stakeholders at all levels.
• Proven track record of making strong business and technical decisions in the face of ambiguity and conflicting requirements.
• Analytical mindset and strong critical thinking and problem-solving skills.
• Ability to handle confidential information with appropriate discretion and judgement.
• Experience developing medical devices under FDA and European Union medical device regulations.
• INCOSE system engineering certification preferred.

Required/Preferred Education and Experience

• BS in electrical, mechanical, computer, biomedical engineering, or related field required.  Advanced degree preferred.

• 15-20 years of engineering experience with at least 8 years in a management role

• Experience developing medical devices under FDA and European Union medical device regulations.

• INCOSE system engineering certification preferred.

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 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.