Principal Software Quality Engineer, Redwood City, CA (Onsite role)

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 Principal Software Quality Engineer is responsible for Quality Assurance activities ranging from software product development (PD) to design transfer, through to sustaining, and then obsolescence. This is a hands-on role where the Principal Software Quality Engineer will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for software design and development per 62304 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 PD projects or assignments. The role will have responsibility for ensuring compliance to process/procedures related to software design and development, risk management, and external standards on topics including cybersecurity and SDLC.  This position will report to Director, Quality Engineering.

• 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:
• Software Design Control Documentation
• Software-related Product specification and Device Master Record
• Systems and/or sub-systems software design verification & validation activities
• Cybersecurity Assessment
• Risk Management
• CAPA /NCMR
• External Standards and Regulatory Audits
• Quality Investigations (CAPA, SW Anomalies)
• Traceability
• Participate in cybersecurity, post market vulnerability assessments, HHEs and other risk management processes
• Support internal and external regulatory audits, regulatory submissions, 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 and promote implementation into the quality system.
• Work with departments to discuss system gaps, fixes, design solutions and risks.

• Project leader on various projects by representing Quality Assurance
• Provide concise updates of critical projects to Senior Management.

• Perform other duties as required

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

• 8 years’ experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.

• Master’s Degree preferred.

• 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.
• Experience with Medical Device Firmware/Software Development
• FDA Software guidance of Verification & Validation
• Active Implantable Medical Device Directives (90/385/EEC)
• Strong understanding and working knowledge of IEC 62304, EN ISO 14971, FDA Software Guidance or similar standards
• Understanding and working familiarity with AAMI TIR 57, AAMI TIR 97, IEC 81001-5-1, IEC 30111.

• Project management skills; capable to lead project teams.

• Highly developed written and oral communication skills and strong collaborator able to guide and influence partnered engineering teams.
• 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) and/or Six Sigma Green/Black belt preferred.

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$144,205 - $198,282 . The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.

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.