Principal Quality Engineer

ZOLL Medical Corporation • San Jose, CA

81d • $180,000 - $195,000 • Hybrid

About The Position

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 throughout 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.
• Experience in the medical device industry in a Quality Engineering and/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.

Nice To Haves

• Previous experience in Quality Engineering in medical device industry is a must.
• Experienced in 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 is required.
• 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.
• 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.

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.
• Oversee product safety and reliability requirements.
• Participate in the assessment of product risk and work with engineers to implement and test risk mitigations.
• Work with R&D on product development projects.
• Collaborate with Manufacturing Engineering on product/process improvement projects.
• Work closely with software, mechanical, and electrical engineers to define system requirements.
• Define 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.

Benefits

• Annual salary for this position is $180K to $195K.
• Eligible for an annual bonus in accordance with the company's bonus plans.
• Comprehensive benefits plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree