Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain.
We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 70,000 patients around the world.
Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy.
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 and quality principles and practices for implantable medical devices and accessories. Role will have responsibility in support of new product development projects ensuring compliance to process/procedures related to design and development, risk management, and external standards on topics including human factors and biocompatibility.
- Follow procedures to guide product development and ensure best engineering practice compliant with relevant regulatory requirements
- Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to:
- Design Control Documentation
- Product specification and Device Master Record
- Design Verification & Validation activities
- Risk Management
- CAPA /NCMR
- External Standards and Regulatory Audits
- Work with departments to discuss system gaps, fixes, design solutions and risks.
- Support internal and external regulatory audits, and other quality assurance functions
- Other duties as assigned
- Bachelor’s degree in a technical or science major.
- 5+ years of Quality/Regulatory experience in a medical device or other regulated industry
- COVID-19 vaccination upon hire, or approved accommodation/exemption
Skills and Knowledge
- 5 years’ experience in an FDA regulated Class 2 or 3 medical device environment compliant to QSR 21 CFR Part 820 and ISO 13485 quality systems.
- Design Control process
- Understand Geometric Dimensioning and Tolerance applications and be able to apply concepts
- Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
- Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) preferred
- Strong understanding of DMAIC and other Six Sigma Tools to investigate and solve high risk issues; Six Sigma Green Belt preferred.
- Strong understanding of ISO14971, IEC 60601; experience with ISO 10993, ISO 14708 preferred
- Experience with Medical Device Firmware/Software Development preferred.
- Project management skills
- 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.