ZOLL Medical Corporation · 1 week ago
Principal Quality Engineer
San Jose, CA
Full-time
Onsite
Senior Level, Lead/Staff
$170K/yr - $199K/yr
7+ years expZOLL Medical Corporation is dedicated to improving patient outcomes through innovative medical technologies. The Principal Quality Engineer will collaborate with the Quality Leadership team to ensure high levels of quality, safety, and effectiveness in product realization, supporting product development and compliance with quality standards.
Health CareMedical DeviceSoftware
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
Qualification
Required
Bachelor's Degree in Electrical Engineering or equivalent is required
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
Previous experience in Quality Engineering in medical device industry is a must
Hands-on experience with electrical, electro-mechanical and software verification and validation requirements is required
Quality System administration, and maintenance in the medical device industry
Demonstrated experience/skill in risk analysis, failure analysis, and CAPA
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
Preferred
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
Experienced in software controlled electrical and electro-mechanical devices is highly preferred
Exposure to sterile disposable products such catheters is preferred
Benefits
Annual bonus in accordance with the company's bonus plan
Comprehensive benefits plans
Company
ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies.
1001-5000 employees
H1B Sponsorship
ZOLL Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (6)
2023 (8)
2022 (8)
2021 (2)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Jon Rennert
CEO
Aaron Grossman
Chief Legal Officer
Recent News
2026-01-13
Business Wire
2025-12-19
Company data provided by crunchbase