Sr. Software Quality Engineer

Company: Nevro Corp.
Location: Redwood City
Posted on: June 2, 2021

Job Description:

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain.

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 70,000 patients around the world.

Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ?65% of patients across six peer-reviewed clinical studies. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy.

The Sr. Software Quality Engineer is responsible for sustaining Quality Assurance activities related to currently released software and firmware. This is a hands-on role where the Sr. Software Quality Engineer will apply diversified knowledge of software engineering, software verification, recognized software development standards and quality principles and practices for implantable medical devices and accessories. This position will report to Manager, Quality Assurance.

• Follow procedures to guide software and systems development and ensure best engineering practice compliance with relevant regulatory requirements
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
  • Risk Management
  • Cyber security Risk assessment
  • Systems Validation
  • Quality Investigations
  • Traceability
  • Software Design
• Participate in cybersecurity, post market vulnerability assessments and other risk management processes
• Support internal and external regulatory audits, and other quality assurance functions.
• Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.
• Demonstrate understanding of software best practices
• Work with departments to discuss system gaps, fixes, design solutions and risks.
• Perform other duties as required

• Bachelor's degree in a technical or science major
• Equivalent work experience may be substituted for education requirement

• 5+ years of Quality /Regulatory experience in a medical device or other regulated industry
• 3 years’ experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• Experience working with Cloud based infrastructure and systems that process, store, and distribute large sets of data continuously.
• FDA Software guidance of Verification & Validation
• Active Implantable Medical Device Directives (90/385/EEC)
• Understand and working knowledge of IEC 62304, EN ISO 14971, AAMI TIR 57, AAMI TIR 97, IEC 60601-4-5IEC 62443-3-1, IEC 30111, FDA Software Guidance or similar standards,
• 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
• Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation
• Must be organized, detail-oriented and adaptable according to evolving situations at hand.
• ASQ Certified Software Quality Engineer (CSQE) preferred.

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Keywords: Nevro Corp., Redwood City , Sr. Software Quality Engineer, Other , Redwood City, California