• Principal DQA Engineer-1417

    Job Locations US-MA-Chelmsford
    Job ID
    2018-1417
    Category
    Research & Development
    Type
    Full-Time/Regular
  • Overview

    ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives.  With customers in more than 140 countries, we continue to expand our reach as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service.  ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest.  From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart.

     

    As a member of our Design Quality Assurance (DQA) Research and Development (R&D) organization for the Resuscitation business, the successful candidate lead test programs that assure continued commercialization of high quality ZOLL products.  We are looking for a highly driven engineer with a passion for product evaluation and a commitment to delivering designs that meet our customers' needs.  We offer the opportunity to work in a collaborative small-team environment where your opportunity to contribute is great.  Join our team of talented engineers to help deliver products that save lives!

     

    Job Summary:

     

    This position reports to the Manager, Design Quality Assurance (DQA) and provides technical leadership and technical oversight to the validation test development and execution work in R&D. The Principal DQA  Engineer  will also be a hands-on  participant  in his/her  assigned product  development  projects  meaning  he/she will  also conduct functional  testing as needed.

     

    As an integral development team member, the Principal DQA Engineer will be an active participant in, and in some cases lead Test Plan reviews with others in R&D. He/she will provide test recommendations to others in DQA and to the development team as needed, especially to other members of the DQA group. The Principal DQA Engineer will also be an active participant in product and subsystem requirements development ensuring that all product requirements are testable and meet clinical needs

    Responsibilities

    • Lead project validation test efforts
    • Implement, review and create validation/verification test cases and test plans
    • Apply risk management principles to guide test plan development.
    • Research and review test equipment specifications to create and refine test cases as needed.
    • Develop and review automated test protocols where appropriate.
    • Perform all testing as assigned
    • Identify, report, and follow up on test failures and observed defects
    • Work with the product development teams to isolate failure modes and capture methods to reproduce product problems
    • Review and create new/enhanced product requirements to ensure that the products are testable and meet both written and implied requirements
    • Mentor less experienced DQA Engineers as needed to teach them how the products work and the proper way to test them

    Qualifications

    • Detailed understanding of the underlying biomedical principles and clinical applications of the products under test and appreciation for the end user clinical needs and practices
    • Nurse, Paramedic or other similar experience a plus
    • Clear and complete understanding of effective software test design especially as it relates to system level testing of embedded systems
    • Sound knowledge of all relevant Medical Device industry standards
    • Demonstrated accomplishments in the development of software and hardware testing processes and programs
    • Proficient with MS/Office, demonstrated ability to learn and use software engineering tools and applications in MS Windows and Linux environments.
    • Excellent written, verbal and interpersonal skills

     

    Required/ Preferred Education and Experience:

    • BS, Software Engineering, Electrical Engineering, Biomedical Engineering or equivalent, advanced degree preferred.
    • 10+ years experience testing software in a product development environment, at least 5 years testing in the medical device industry

     

    Other Duties:

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

     

    ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

     

    #LI-JB1

     

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