Principal Quality Engineer

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.

Essential Functions

• 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

Required/Preferred Education and Experience

• 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

Knowledge, Skills and Abilities

• 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 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

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

The annual salary for this position is:

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.