SENIOR QUALITY ENGINEER

About Nevro

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.

Job Summary & Responsibilities

The Sr. Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing.

This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, software verification, supplier management and quality principles and practices for implantable medical devices and accessories.

This position will report to Manager, Quality.

• Responsible for execution of quality assurance and quality systems application within the department and across departments
• Project leader on various projects by representing Quality Assurance
• Develop inspection and sampling plans
• Work with outside testing laboratories and representatives from other departments
• Support with Supplier Management and transfer to manufacturing. Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Perform / Lead Supplier Audits per audit and business requirements
• Perform data collection and analysis to monitor test results trends
• Perform failure analysis by collaborating with Engineering on investigation as needed
• Perform data collection and analysis to monitor test results trends
• Help with Medical device software development
• Perform, coordinate, review, approve, and / or provide guidance on :
• Product Verification & Validation activities
• Computer System Validation
• Product specification
• DHFs, DMRs, DHRs
• Usability Study
• Risk Management
• External Standards
• Corrective action mitigation
• Perform other duties as required

Role Requirements

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

Skills and Knowledge

• 3 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.
• Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
• Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485),
• FDA Software guidance of Verification & Validation
• Active Implantable Medical Device Directives (90 / 385 / EEC) or Medical Device Regulation (MDR)
• Understand and working knowledge of IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, 62366-2, EN 556-1, EN ISO 11135, EN ISO 10993, ASTM D4169, FDA Software Guidance or similar standards, Soldering Standards (IPC-A-610)
• Design Control process
• 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.

Target Pay Range

$107,858 - $134,822. 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.

EEO Statement

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.