Software Validation Engineer, Team Lead - Robotics

US, US, CA - San Diego

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: No travel required

Location: CA - San Diego

Ref#: 100245

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Job Description

As a Validation Engineer, you will be a part of our Surgical Intelligence team, responsible for ensuring the quality of medical device software and hardware meets the design requirements, as well as ensuring the design requirements are testable.  Additional responsibilities will include:

    Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation.Execute protocols/test scripts and document results.Generate and/or update summary reports.Participate in process improvements.Ensure compliance with FDA device regulatory requirements, including DHF and 510(k).Follow internal Standard Operating Procedures, including documentation of testing procedures.Using problem tracking software, report issues discovered during testing.Communicate with Hardware and Software Development, Marketing, Technical Services, and other project team members to ensure schedules and requirements are consistent with project expectations.Maintain design verification and validation documentation in accordance with established departmental and corporate procedures.Train individuals involved in verification and validation activities as needed.Participate in review and update of SOPs in the spirit of continuous improvement.Possess excellent verbal and written communication skills.

    Basic Qualifications
    • B.S. Degree in Computer Science, Engineering or related technical discipline
    • 4 or more years relevant work experience
    • Knowledge of testing medical products
    • Knowledge of FDA/cGMPs and global regulatory for Medical Devices
    • Good understanding of testing methodology and software development life cycle
    • Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures, including documentation of the testing procedures
    • Ability to handle multiple tasks while ensuring timely and accurate completion
    • Proficient in developing test plans, protocols/test scripts, result reports
    • Proficiency with Microsoft Office with a strong ability to write business reports and correspondence as well as the ability to speak effectively before groups of customers, employees, and management of organization
    Preferred Qualifications
    • Experience with testing for medical device hardware/software
    • Experience with oscilloscope, DVM and other electronic measurement devices
    • Experience working in a Continuous Integration environment
    • Familiar with Agile/Scrum development methodologies
    • Experience testing embedded medical devices at system level (includes software and peripheral hardware components)

    NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.

    About NuVasive
    NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com. 
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