Principal Quality Engineer

ZOLL Medical•San Jose, CA

7d•$170,000 - $198,700

About The Position

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 Medical Corporation 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. Job Summary As a Principal Quality Engineer, you will collaborate with the Quality Leadership team and other cross-functional individuals at all levels to ensure high levels of quality, safety and effectiveness are maintained thorough all phases of product realization in compliance with the corporate quality system, the QSR and the applicable ISO Standards. You will provide support to product development for product assurance and reliability testing, risk analysis, verification and validation activities, and manufacturing support.

Requirements

Bachelor's Degree in Electrical Engineering or equivalent is required.
Minimum 7-10 years of experience in the medical device industry in a Quality Engineering capacity required
Previous experience in Quality Engineering in medical device industry is a must
Experienced in software controlled electrical and electro-mechanical devices is highly preferred.
Hands-on experience with electrical, electro-mechanical and software verification and validation requirements is required.
In depth knowledge of Design of Experiments, Process Capability Studies, Failure Mode, and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing
Thorough knowledge of QSR and ISO 13485 (2003) requirements in a Class III environment
Able to support development of products from initial concept to commercial product
Knowledge of UL and IEC standards for device compliance
Attention to detail, good organization, good interpersonal skills, good communication skills and ability to multitask
Team player with strong customer orientation, proven leadership and technical skills

Nice To Haves

Experience in the medical device industry in a Quality Engineering and or Test Engineering capacity is desired
Software controlled/electronic medical devices preferred
Supplier Quality Assurance preferred
Exposure to sterile disposable products such catheters is preferred
Understanding of sterilization process, environmental monitoring, biocompatibility requirements is a plus
Quality System administration, and maintenance in the medical device industry
Demonstrated experience/skill in risk analysis, failure analysis, and CAPA

Responsibilities

Ensure that the products are of high quality, safe, and effective at all stages of product realization process through the implementation and maintenance of an effective manufacturing quality assurance and quality control system
Oversees product safety and reliability requirements.
Participates in the assessment of product risk and works with engineers to implement and test risk mitigations
Work with R&D on product development projects.
Work with Manufacturing Engineering on product/process improvement projects.
Works closely with software, mechanical, and electrical engineers to define system requirements
Define a verification/validation requirements for hardware and software and develop protocols in conjunction with appropriate functions, perform analyses, and document results in a report format consistent with process requirements
Investigate and analyze failures.
Recommend and implement corrective and preventive measures 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 present standards and establish proposed quality expectancy of finished product.
Recommend modifications of existing products, materials, or components to achieve the established quality standards and overall reliability standards
Coordinate factory inspection by regulatory agencies certifying the products for electrical safety and EMC
Perform inspection and testing of the products as assigned