Principal Systems Engineer

About the Company

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 outcomes for cardiac patients. Key products include:

• LifeVest: The world's first wearable defibrillator, trusted to protect over 1 million patients at risk of sudden cardiac death.
• HFMS (Heart Failure Management System): A non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmission rates by 38 percent.
• TherOx Super Saturated Oxygen (SSO2) Therapy: The first FDA-approved therapy since the stent (over 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 ensure cardiac patients receive the life-saving therapy they need. ZOLL has been recognized as Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and one of Pittsburgh's Coolest Offices.

About the Role

The Principal Systems Engineer is responsible for a methodical, disciplined approach to the conception, design, development, and technical management of ZOLL's product realization process. This role collaborates with New Product Planning and Product Management to define patient and stakeholder needs, translating them into engineering system-level requirements and establishing essential functionality early in the product development cycle.

The Principal Systems Engineer leads major activities of the multi-functional engineering team throughout the product development lifecycle, including system requirements, architecture, detailed design, peer reviews, and predictive/analytical methodologies. The role also supports engineering verification, reliability testing, FMECA analysis, and risk management.

Responsibilities

• Collaborate with New Product Planning, Product Management, Medical Affairs, Regulatory Affairs, Human Factors, and others to identify and prioritize patient and stakeholder needs during early development (concept through design output). Activities include customer interviews, use case development, and feature set prioritization.
• Drive the generation of system-level and detailed engineering requirements from market requirements and needs.
• Lead cross-functional approval of system-level and detailed engineering requirements.
• Define system architecture and collaborate with the engineering team to refine it.
• Guide the R&D team to identify technical investigations addressing architectural unknowns and risk areas.
• Assist the R&D team with test case generation for system-level and detailed requirements.
• Collaborate with the CMS Regulatory Risk Manager to assess product risk using ZOLL’s Risk Management process during design, verification, and validation.
• Work with engineering managers and technical program managers to identify resource needs.

Requirements

• B.S. or M.S. degree (or equivalent industry experience) in engineering or a related discipline.
• Minimum of 10+ years of product development experience.
• 15+ years of industry experience with FDA-regulated devices (strongly preferred).

Skills

• Proven track record in systems engineering duties and responsibilities.
• Demonstrated ability to plan, direct, and conduct engineering research and development activities.
• Strong conflict resolution, analytical, and decision-making skills.
• Excellent verbal and written communication skills.

Working Conditions

• Position is located at ZOLL Cardiac Management Solutions offices.
• Evening and weekend work may occasionally be required.
• Primarily sedentary role with occasional standing, walking, and lifting up to 25 pounds.

Pay

The annual salary for this position is $170,000 to $190,000. Factors affecting starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.

Benefits

Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.