Principal Quality Engineer

Overview

Acute Care Technology

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 develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally.

Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. 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.

Principal Quality Engineer

• Collaborate with the Quality Leadership team and cross-functional partners at all levels to ensure high levels of quality, safety and effectiveness throughout all phases of product realization in compliance with the corporate quality system, the QSR and applicable ISO standards.
• Provide support to product development for product assurance and reliability testing, risk analysis, verification and validation activities, and manufacturing support.
• Ensure products are of high quality, safe, and effective by implementing and maintaining an effective manufacturing quality assurance and quality control system.
• Oversee product safety and reliability requirements; participate in risk assessment and work with engineers to implement and test risk mitigations.
• Collaborate with R&D on product development projects and with Manufacturing Engineering on product/process improvements; coordinate with software, mechanical, and electrical engineers to define system requirements.
• Define verification/validation requirements for hardware and software, develop protocols, perform analyses, and document results in a report format aligned with process requirements.
• Investigate and analyze failures; recommend and implement corrective and preventive actions as necessary.
• Provide training and assistance to inspectors.
• Develop, implement and maintain inspection and test methods for finished products and incoming components and materials; evaluate precision and accuracy of testing, measurement and production equipment.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with engineering staff to determine quality and reliability standards.
• Develop and analyze statistical data and product specifications to determine current standards and establish proposed quality expectations; recommend modifications of existing products, materials, or components to achieve quality and reliability standards.
• Coordinate factory inspections by regulatory agencies certifying products for electrical safety and EMC.
• Perform inspection and testing of products as assigned.

• Bachelor s Degree in Electrical Engineering or equivalent is required; experience in the medical device industry in a Quality Engineering or Test Engineering capacity is desired.
• Minimum 3 years (Quality Engineer) or minimum 5-7 (Sr. Quality Engineer) or 7-10 years of experience in the medical device industry in a Quality Engineering capacity required.
• Software controlled/electronic medical devices preferred.
• Supplier Quality Assurance preferred.

• Previous experience in Quality Engineering in the medical device industry is required.
• Experience with software controlled electrical and electro-mechanical devices is highly preferred; exposure to sterile disposable products such as catheters is preferred.
• Hands-on experience with electrical, electro-mechanical and software verification and validation requirements; understanding of sterilization processes, environmental monitoring, and biocompatibility requirements is a plus.
• Quality System administration and maintenance in the medical device industry.
• Demonstrated experience in risk analysis, failure analysis, and CAPA.
• Knowledge of Design of Experiments, Process Capability Studies,…