Job description

CMS 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. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world: LifeVest , the world s first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death. HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent. TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20 years ago to reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been Pittsburgh s Manufacturer of the Year, one of Western PA s Healthiest Employers, and even one of Pittsburgh s Coolest Offices. But it s our unique opportunity to impact people s lives that makes ZOLL the ideal place to build your career. 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. 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 the CMS Regulatory Risk Manager to help the R&D team to assess product risk using ZOLL’s Risk Management process during the design, verification, and validation phases of the project. Collaborates with engineering managers and technical program managers to identify resource needs. Required/Preferred Education and Experience B.S. or M.S. degree or equivalent industry experience in engineering or a related discipline required Minimum of 10 years of product development experience required 15 years industry experience with FDA regulated device strongly preferred Knowledge, Skills and Abilities Proven track record performing the above Duties and Responsibilities. Demonstrated ability to plan, direct, and conduct engineering research and development activities. Strong conflict resolution, analytical and decision-making skills. Strong verbal and written communication skills. Physical Demands While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Working Conditions This position is located at ZOLL Cardiac Management Solutions offices. Evening and weekend work may at times be required. 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. The annual salary for this position is: $170,000.00 to $190,000.00 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 www.zollbenefits.com . 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.

Requirements

Must-haves

LifeVest , the world s first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20 years ago to reduce infarct size in patients with the most severe heart attacks.
Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.
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 the CMS Regulatory Risk Manager to help the R&D team to assess product risk using ZOLL’s Risk Management process during the design, verification, and validation phases of the project.
Collaborates with engineering managers and technical program managers to identify resource needs.
B.S. or M.S. degree or equivalent industry experience in engineering or a related discipline required
Minimum of 10 years of product development experience required
Knowledge, Skills and Abilities
Proven track record performing the above Duties and Responsibilities.
Demonstrated ability to plan, direct, and conduct engineering research and development activities.
Strong conflict resolution, analytical and decision-making skills.
Strong verbal and written communication skills.
Physical Demands
While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.
Working Conditions
$170,000.00 to $190,000.00

Nice-to-haves

Required/Preferred Education and Experience
15 years industry experience with FDA regulated device strongly preferred

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long