Nevro Redwood City , CA 94063
Posted 2 months ago
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 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
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Role Requirements
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)
Skills and Knowledge
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.
Target Pay Range
$86,422 - $118,831 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.
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