Quality Engineer (IPG) Shift B

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.

Nevro is seeking a Quality Engineer that will play a key role in ensuring manufacturability and testability of product designs and ensure supply chain, manufacturing processes, tools and equipment are in place and capable of delivering implantable Neuromodulation system´s devices for pain management. This position reports to the Section Quality Leader.  This position will be located in the Coyol FTZ Park in Costa Rica.

The Quality Engineer is responsible to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices. This is a hands-on role where the Quality Engineer will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for implantable medical devices and accessories. Will work independently with little to no supervision and exercise considerable discretion in determining objectives and approaches to significant organizational projects or assignments.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Applying knowledge of QSR and GMP requirements on a daily basis, the duties and responsibilities for this position include, but are not limited to, the following:

• Establish and Maintain Receiving Inspection procedures to support product and receiving inspections.
• Write, review and/or approve validation plans, protocols and reports (e.g., cleanroom, equipment) in accordance with applicable regulatory requirements and Nevro SOPs.
• Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria.
• Collaborate with cross functional teams in Costa Rica, and Redwood City, CA to implement and align Quality Control inspection plans, requirements, and methodologies.
• Provide guidance to manufacturing processes and personnel.
• Work with cross-functional team to implement comprehensive preventative maintenance work instruction as well as revalidation requirements.
• Work with production and inspection staff to analyze, evaluate, understand and resolve any assembly inconsistencies or product/production issues.
• Review and disposition Non-conformance reports. Perform Root Cause analysis in order to determine corrective and preventive action activities.
• Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions and Device Records.
• Evaluate risk, manage risk assessment activities and create associated documentation.
• Investigate and implement solutions to internal and external audit findings.
• Lead Supplier management and Supplier Quality activities for local suppliers.
• Collaborate with Suppliers, as appropriate to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet Nevro and applicable regulatory requirements.
• Participate in audits (internal & external) and regulatory agency inspections.
• Responsible for review/release of Batch Record(s) and review of other documentation from medical device manufacturing and packaging suppliers, and ensure that all activities comply with quality requirements and Nevro procedures.
• Responsible for performing Quality assessment of changes to manufacturing processes, materials, and procedures and ensure applicable and appropriate documentation are generated.
• Supervise Quality Inspectors and Technicians.
• Ensure compliance of the organization's management systems to guarantee effectiveness and adherence to established policies, standards, and regulatory requirements.
• Perform other duties as required.

• Bachelor’s degree in relevant technical discipline required; advanced degree preferred.
• Equivalent years of experience may be substituted for education requirement

• No fewer than four (4) years of directly related experience, with at least two (2) of those years in a class II or III medical device environment, preferably in implantable device;
• Experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO 13485) and Implantable Medical Device Directive;
• 2+ years in Quality Assurance and/or Quality Systems function in the Medical Device industry;
• Prior experience working with US companies a plus.
• Knowledgeable with the ISO Requirements and QSR requirements;
• Strong communication skills, both verbal and written, and the ability to effectively communicate throughout all levels of the organization;
• Experience in managing quality system activities not limited to product audits, CAPA and supplier corrective action request (SCAR);
• Cross-functional collaboration with Quality, Regulatory, Engineering, Manufacturing/Production, Supply Chain, etc;
• Strong working knowledge of quality system processes, validations and audits (internal and external);
• Strong problem-solving, organizational, analytical and critical thinking skills
• Root cause analysis and implementation of corrective action for process related concerns;
• Knowledge on sterilization and biocomptability is a plus;
• Experience performing Quality inspection to ensure products and processes comply with the relevant requirements of the QMS;
• Analyze failure, corrective and preventive action to respond to internal/external customer complaints;
• Ability to travel on needed basis;
• Ability to work closely with peers in Redwood City, CA
• Ability to multi-task, work under pressure and meet deadlines required;
• Ability to effectively present information and respond to questions from groups of managers, clients, and the customers;
• Ability to communicate fluently in Spanish, both verbal and written.
• Ability to communicate fluently in English, both verbal and written.

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.

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.