Senior Software Quality Engineer

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. The company is focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment.

We started with a simple mission to help more patients suffering from debilitating pain and developed our proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 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®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. 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.

The Sr. Software Quality Engineer is responsible for the design and development Quality Assurance activities related to new software products. This is a hands-on role where the Sr. Software 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. This position will report to Associate 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:
• 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

• 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.
• 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 60601-4-5, IEC 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.

$125,250 - $172,220 . 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.