Requires Bachelor's degree in Mechanical Engineering, Industrial Engineering, Industrial Engineering Management, Regulatory Affairs, Regulatory Science, or related field and 7 years of progressive post-baccalaureate experience as a quality engineer, validation engineer or any quality assurance occupation in medical device or regulated industry. Must possess 5 years of experience with: -FDA regulated Class 2 or 3 medical device environment compliant to QSR 21 CFR Part 820 and ISO 13485 quality sy... more details
Principal Quality Engineer
Job LocationsUS-CA-Redwood City
Job Post Information* : Posted Date16 hours ago(6/13/2024 4:38 PM)
ID
2024-4511
Category
Quality
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
Principal Quality Engineer, Redwood City, CA - Perform Quality Assurance activities ranging from product development through transfer to manufacturing for implantable medical devices and accessories. Support new product development projects ensuring compliance to process/procedures related to design and development, risk management, and external standards on topics including biocompatibility, human factors and sterilization. Guide product development and ensure best engineering practices compliant with relevant regulatory requirements. Assess when medical device change/modification/project is subject to formal design control process. Review new/modified products ensuring test plans and test procedures demonstrated design/process conformance. Ensure compliance to applicable standards like 21CFR Part 820, ISO13485, and AIMDD. Participate on Project Teams by providing input on adequacy of engineering approaches selected and device product designs. Assess qualification and management of external suppliers in manufacturing. Develop and conduct biocompatibility device assessments for new product development and support revalidation for sustaining biocompatibility projects (ISO10993). Determine device sterilization requirements and ensure method and associated packaging are validated (ISO11135, ASTM D4169, ISO 11607). Support labeling review and approval (ISO 15223). Develop 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; Human Factors evaluations; Risk Management; CAPA /NCMR/ HHEs; internal and external Regulatory Audits. Direct product development teams through completion of design control phases: Input, Output, Verification, Clinical Readiness, Validation, and Market Release. Support design transfer activities, reviewing test method validation, process and tools validations, application of lean six sigma tools, Design of Experiments. Support supplier identification for new products and conduct supplier qualifications and audits. Review and approve documentation deliverables associated with each design control phase. Identify potential hazards associated with device design, estimate/evaluate/control associated risks. Maintain Risk Management File including Risk Management Plan, Risk Analysis & Evaluation Worksheet, Risk Management Report. Conduct FMEA evaluations of products considering device use, design, and process (ISO14971). Examine information sources for hazards or product deficiencies and address via CAPA system. Complete projects by representing Quality Assurance. Execute elements of Design Control Improvement Plan and Risk Management Improvement Plan. Work with departments to discuss system gaps, fixes, design solutions and risks using Quality auditing, CAPA. Provide concise updates of critical projects to senior management. Remote work permitted at employer’s discretion. (No agencies or phone calls please.) #LI-DNI
Remote work is permitted at the employer’s discretion.
Role Requirements
Requires Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Industrial Engineering Management, Regulatory Affairs, Regulatory Science, or related field and 7 years of progressive post-baccalaureate experience as a quality engineer, validation engineer or any quality assurance occupation in medical device or regulated industry.
Must possess 5 years of experience with:
-FDA regulated Class 2 or 3 medical device environment compliant to QSR 21 CFR Part 820 and ISO 13485 quality systems.
- ISO13485 Auditor
-Investigating and solving high risk issues with DMAIC and other Six Sigma Tools (i.e: Six Sigma Black Belt)
- ISO 10993, ISO 11135, ISO 11607, ISO14971, ISO15223-1, IEC62366
Up to 25% travel, domestic and international trips
Target Pay Range
$145,000 to $155,958
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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