Nevro Corp.

  • Principal Quality Engineer

    Job Locations US-CA-Redwood City
    Job Post Information* : Posted Date 1 month ago(10/8/2018 5:03 PM)
    ID
    2018-2400
    Category
    Quality
  • About Nevro

    Nevro (NYSE: NVRO) is a public multinational medical technology company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform.

     

    We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 36,000 patients around the world.

     

    The Nevro® Senza® SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.

    Overview

     The Principal Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Principal Quality Engineer will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for implantable medical devices and accessories. Will work independently with little to no supervision and exercise considerable discretion in determining objectives and approaches to significant organizational projects or assignments.

    Role Requirements

    • Bachelor’s degree in a technical or science major
    • 10+ years of Quality/Regulatory experience in a medical device or other regulated industry
    • Recognized ISO 13485 Lead auditor training certificate preferred
    • Act as a mentor on execution of quality assurance and quality systems application within the department and across departments
    • Project leader on various projects by representing Quality Assurance
    • Oversee the maintenance of QSR, GLP, GMP and FDA compliance standards and keeps up-to-date on current regulations and industry standards
    • Perform failure analysis by collaborating with Engineering on investigation
    • Strong understanding of DMAIC and other Six Sigma Tools to investigate and solve high risk issues
    • Lead Supplier management and Supplier manufacturing activities
    • Provide concise updates of critical projects to Senior Management.
    • Perform, coordinate, review, approve, and/or provide guidance on:
      • Bioburden, LAL and Environmental testing
      • Product Verification & Validation activities
      • Product specification
      • DHFs, DMRs, DHRs
      • Biocompatibility activities
      • Sterilization validations and follow up validations
      • CAPA/SCAR/NCMR
      • Risk Management
      • External Standards
    • Perform other duties as required

    Skills and Knowledge

    • 10 years working experience in a regulated industry
    • 4 years auditing experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
    • Experienced with Medical device software development
    • Project management skills
    • Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
    • Understand Geometric Dimensioning and Tolerance applications and be able to apply concepts
    • Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485)
    • Active Implantable Medical Device Directives (90/385/EEC)
    • Understand and working knowledge of IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1 and 62366-2, EN 556-1 and EN ISO 11135, EN ISO 10993, ASTM D4169 or similar standards, Soldering Standards (IPC-A-610)
    • Design Control process
    • Lead project teams
    • Highly developed written and oral communication skills and be able to work in a team environment
    • Must have good problem solving skills and be able to work independently
    • Stability or Expiry Dating validations
    • Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation
    • Must be able to professionally present to management and interface with all departments, represent the company professionally to suppliers, and third party auditors.
    • Must be organized, detail-oriented and adaptable according to evolving situations at hand.

    #LI-AL1

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    Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.

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