Principal Quality Engineer - Nevro Corp.

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 Principal Quality Engineer is responsible for Quality Assurance activities including but not limited to managing Quality System activities, Sustaining Engineering Product Lifecycle Management, Nonconformance investigations, CAPA escalations, Supplier Management and related Audit files, Product cleaning and sterilization process.

This is a hands-on role where the Principal Quality Engineer will apply diversified knowledge of Engineering, Risk Management, Supplier Management, and Quality principles and practices for the manufacturing of implantable tissue and medical devices as well as the related surgical tools. This position will report to the Management Representative and Associate Director, Quality Systems at the Nevro (VYRSA) facility in King of Prussia, PA.

• Product areas: Class-I and Class-II sacroiliac joint implants & reusable surgical instruments
• Engineering areas: Sustaining, Mechanical, Materials, Hardware
• Quality Systems areas: Complaint, Nonconformance, Inspection, Failure Analysis, Lot History Records, Audit, CAPA, Supplier, Change Control, Document Control, Training, and Metrics
• Serve as Product Quality lead:
  Investigate, monitor, document and trend product and process Nonconformances and Supplier defects. Support ongoing product improvement initiatives. Assess impact to form, fit and function for SIJ implants and surgical tools resulting from engineering and supplier process changes. Evaluate and monitor product quality through base business, nonconformance, complaint and failure investigations.
• Serve as Supplier Quality lead:
  Create and maintain supplier files, draft supplier audit plans, perform remote or on-site supplier audits, write and release supplier audit reports, maintain supplier metrics, oversee supplier corrective actions. Review and complete supplier change notifications. Initiate supplier process improvements as required. Occasional travel to external supplier sites for audits, evaluation and production support as required (anticipate up to 10% travel).
• Serve as Quality Systems point of contact:
  Partner effectively with the local team comprising of Engineering, Supply Chain, Operations, and Warehouse staff to provide quality guidance, advise, and complete internal documentation related to Audit, CAPA, Complaints, Change Orders, and Training. SME/onsite Lead for Internal and Notified Body Audits and Inspections as required.

• Additional Responsibilities and upcoming projects include:

• Process definition and execution of Cleaning Validations for reusable surgical instruments.
• Partner with outside testing laboratories and representatives as needed.
• Maintain compliance and readiness for inspection of assembly floors via Kaizen and GMP controls.
• Align, improve and maintain process documentation, forms and guidance documents.
• Review manufacturing process inspection documents and production test methods.
• Develop and document inspection and sampling plans.
• Perform data collection and analysis to monitor test results trends.
• Review Post-Market Quality data on a regular cadence.
• Regularly, perform, coordinate, review, approve, and/or provide guidance on:
• Process Validations: IQ, OQ, PQ
• Product specifications and process documentation
• External Standards
• DHFs, DMRs, DHRs
• Risk Management
• Failure Analysis
• Health Hazard Evaluations
• Corrective & Preventive Actions
• Nonconformances
• Supplier Corrective Actions
• Audit & Inspection Reports

• Perform other duties as assigned.

 

 

 

Role Requirements:

• Bachelor's degree in engineering, business, technical or science major.
• 8-10 years of hands-on Quality experience in the medical device industry.
• Direct experience working on Class-I or Class-II medical devices;
  preferably on orthopedic implants, reusable surgical instruments, and human tissue products.
• Ability to work effectively under minimal supervision.
• Ability to interpret and apply Quality System Regulations and External Standards.
• Ability to provide support and guidance to team members across multiple functions and locations.
• Ability to apply proactive, systematic problem-solving methodologies while identifying, prioritizing, communicating, documenting and resolving quality issues.

Skills and Knowledge:

• Understanding and working knowledge of ISO 9001, ISO 10993, ISO 11135, ISO 14971, and ISO 27001.
• Auditing certification and/or experience in FDA regulated Class I, II, or III medical device environment following QSR 21 CFR Part 820, QSR 21 CFR Part 1271, EU MDR, and ISO 13485 Quality Systems.
• Working knowledge of Corrective and Preventive Action methodology and Nonconformity investigations.
• Process Validation knowledge of IQ, OQ, PQ, Test Method Validation and Sampling Plans.
• Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans.
• Excellent presentation skills including dashboard, summaries, statistical tools, and project planning.
• Excellent communication, collaboration, and presentation skills.
• Team player with proven self-accountability who is organized, detailed, and adaptable.
• Strong investigation and problem-solving skills and able to work independently.
• Knowledge and application of ASQ CQE or Six Sigma tools preferred. 

Target Pay Range:

$132,979 - $166,224. 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.