Design Quality Engineer II

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.

The Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Quality Engineer will apply diversified knowledge of engineering, verification and quality principles and practices for implantable medical devices, product software and accessories.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Follow procedures to guide 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 development and validation across product development teams, including:
• Risk Management
• Cyber security risk assessment
• Systems, Software, Electrical and/or Mechanical design
• Design/Software Verification and Validation
• Human Factors
• Quality Investigations
• Design Transfer (Manufacturing review, Inspection methods development, Test Method Validations, Biocompatibility, Sterilization assessments, etc.)
• Software Design and Configuration management
• Support risk management processes and initiatives.
• Support internal and external regulatory audits, and other quality assurance functions.
• Define or identify potential compliance gaps and assess new regulations and standards, against existing or developing products.
• Work with departments to discuss quality system gaps, fixes, design solutions and risks.
• Perform other duties as required

#LI-JS1

• Bachelor’s degree in science or engineering
• Equivalent work experience may be substituted for education requirement.
• 3+ years of Quality/Regulatory experience in a medical device or other regulated industry environment(s)

• Proficiency with medical device development life cycles specifically to design control and transfer related manufacturing processes and technologies
• Knowledge and working experience with Software Development LifeCycle processes, Good Manufacturing Practices, Good Documentation Practices, Design Control, and/or Corrective Action & Prevention methodology
  • Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans, preferred
• Understanding of EN ISO 14971, IEC 60601-1, IEC 62304, FDA Software Guidance and/or similar standards
  • Experience with ISO14708 or Active Implantable Medical Device Directives (90/385/EEC), preferred
• 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.
• Ability to effectively present information and respond to questions from groups of managers, clients, and the customers.
• Must be organized, detail-oriented and adaptable according to evolving situations at hand.

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.