Senior Software Design Quality Engineer

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.  

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response¹.Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. 

Nevro also recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

The Software Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing, with an emphasis on design controls pertaining to software development. This is a hands-on role where the Software Design Quality Engineer will apply diversified knowledge of software design and development as per 62304, software verification, recognized software development standards, and quality principles and practices for implantable medical devices and accessories.

• 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
• Configuration management
• Lead 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.

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• 5+ years of Quality/Regulatory experience in a medical device or other regulated industry
• Bachelor's degree in a technical or science major

• 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.
• Have working knowledge of the following:
• 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.
• Must be organized, detail-oriented and adaptable according to evolving business needs.
• ASQ Certified Software Quality Engineer (CSQE) preferred.

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.