Principal Systems Engineer

ZOLL Medical•Pittsburgh, PA

4d•Onsite

About The Position

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.

Requirements

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
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.

Nice To Haves

15+ years industry experience with FDA regulated device strongly preferred

Responsibilities

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.