In this highly visible role, you will be key in bringing about the release of new Nevro product designs, independently providing the quality “voice” and guidance on subjects such as product design requirements/documentation, risk management, human factors, and biocompatibility. You will ensure compliance to external standards, regulations, and Nevro’s QMS related to these areas. Your experience in managing projects from a quality design perspective from start to finish within an FDA regulated Class II or III environment will be important to your success.
The role is highly interactive with Design/Development teams and therefore candidates within the SF Bay Area are desired.
In this hands-on role from product development through transfer to manufacturing, you will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for implantable medical devices and accessories. You will work independently and exercise considerable discretion in determining objectives and approaches to significant organizational projects. You will support new product development projects ensuring compliance related to design and development, risk management, and external standards on topics including DfX, 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
External Standards and Regulatory Audits
Project leader on various projects by representing Quality Assurance
Work with departments to discuss system gaps, fixes, design solutions and risks.
Provide concise updates of critical projects to Senior Management.
Support internal and external regulatory audits, and other quality assurance functions
Skills and Knowledge:
Bachelor’s degree in a technical or science major. Master's Degree preferred.
8 years of Quality/Regulatory experience in an FDA regulated Class 2 or 3 medical device environment compliant to QSR 21 CFR Part 820 and ISO 13485 quality systems, or other regulated industry.
Strong understanding of DMAIC and other Six Sigma Tools to investigate and solve high risk issues.
Six Sigma Green Belt preferred.
Design Control process
Strong understanding of ISO14971, IEC 60601; experience with ISO 10993, ISO 14708 preferred.
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.
Experience with Medical Device Firmware/Software Development preferred.
Project management skills; capable to lead project teams.
Highly developed written and oral communication skills and be able to work in a team environment, while also able to work independently.
Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation.
Must be organized with good problem-solving skills, be detail-oriented and adaptable according to evolving situations at hand.
Must be able to professionally present to management and interface with all departments, represent the company professionally to suppliers, and third-party auditors.
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.