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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:   - Responsible for the development and maintenance of quality programs, systems, processes and procedures to ensure internal and regulatory standards compliance requirements are followed, implemented per requirements. - Manage the coordination of Quality (monthly and quarterly) metrics, analyze trends, drive continuous process improvements and generate reports related to the Quality System performance:   - Preparing/support site Quality Management System metrics (QMR, CAPA, NCMR, IAs, etc.), presentation and post-review minutes and action items. - Perform site data analysis - Preparing and issuing periodic Quality data and dashboards to Management and HQ. - Support/Administrate CAPA/IA program by maintaining the strategy, systems and tools to ensure a robust corrective and preventive actions, tracking of Action completion, and assessment of effectiveness, as appropriate. - Support and/or Lead the coordination of internal/external/supplier Quality System audits. Participates in internal and supplier and external regulatory site visits, inspections, and audits. Including ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, follow up to ensure audit action items are closed, etc. - Lead cross functional teams to execute Quality System initiatives. As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member) - Draft, review, and update QMS documents including the processing of new document and document revision requests. - Ensure the consistency and quality of documents by editing and proofreading documents prior to release. - Schedule and execute periodic document reviews to ensure documents are compliant with Nevro requirements and processes as well as external regulations. - Supports investigating and resolving system nonconformance’s (related to Quality Systems). - Responsible for new hire orientation related to quality topics. - Apply proactive, systematic problem-soling methodologies in identifying, prioritizing, communication and resolving quality system issues. - Perform other duties as assigned.

The Lead Quality Test Engineer tests and repairs electronics, designs test fixtures and tools, and applies diversified knowledge of engineering principles and practices to their job.   The Lead Quality Test Engineer works cross-functionally with other engineers on complex root cause analyses, as well as to elevate possible issues found in the field. Additionally, they work closely with internal customers to present technical information to non-technical customers, as well as to gather complaint details as needed for the investigation of the returned product. - Manage and maintain the returned product investigation lab. - Analyze returned products to confirm reported complaints, identify failure modes and determine root causes. - Adapt and refine test procedures to properly address customer complaints. - Design and develop test equipment and test specifications. - Differentiate between hardware and software failures. - Perform board level circuit analysis. - Collaborate cross-functionally on complaint investigations. - Drive continuous improvement of the quality systems and processes. - Write and maintain SOPs, WI’s, audit reports and other documentation as required. - Identify, generate, and publish metrics and reports related to quality issues. - Be available as a knowledge resource/ subject matter expert (SME) to other team members. - Other duties as assigned.

The Software Verification Engineer will play a key role in the development of a Class III implantable Neuromodulation system for pain management, working cross-functionally to help verify firmware, software applications, and whole systems and make sure that all stakeholders are aligned, and requirements and user needs are met. - Designs, develops, updates, executes, and debugs firmware, software, and/or system tests (manual, interactive, automated) and maintains testing metrics. - Owns and optimizes system, sub-system, and module verification and validation efforts to ensure complete system coverage and provide proper tracing. - Reviews and evaluates product requirements for correctness, completeness, and testability and analyzes and allocates a set of requirements into an appropriate set of verification tests. - Conducts and participates in cross-functional reviews of the test protocol development (test strategy, test design, test code). - Performs hands-on system integration testing and troubleshooting of technical issues, working with developers to identify root causes and viable resolutions, document issues found, and verify bug fixes of software defects. - Completes regression, dry, and formal verification runs for multiple firmware and software releases at appropriate times in the development cycle. - Tracks defects and validates bug fixes. - Owns technical documentation such as engineering reports, verification plans, procedures and reports, and validation plans and reports. - Develops and validates software and hardware-based tools to assist in development and testing. - Assesses new test technologies via reviews of the state of the art or by performing proof of concept work and communicates the results of the assessment to members of the development organization. - Other duties as assigned.

(Must live in the SF Bay Area)   The Principal Regulatory Affairs Specialist  will be part of this high-performance team and responsible for developing regulatory strategies, preparing U.S. and major market submissions and obtaining approval to introduce new spinal implants and biologics worldwide. These responsibilities are performed through the collaboration with various functions across the Operating Unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality and Marketing. Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements.  The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new solutions based on experience and working collaboratively within the Regulatory department other business functions. - Support New Product Development on project teams on behalf of RA, developing and implementing Regulatory strategies and deliverables for US, EU and International (OUS). - Participate on the Product Development team and responsible for identifying submission deliverables, timelines, and strategic direction.  Reviews and approves technical documentation. - Prepare regulatory submissions such as US pre-submissions, 510(k)s, IDE,  and Letter-to-File submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. - Provide product change assessments and define regulatory impact of product changes for Class II, Class I and biologics (bone graft)products. - Attend internal and external audits/inspections in a Regulatory capacity and address any issues or concerns, and support the Quality System Management Representative, as appropriate. Provide guidance to the team on change assessments and reportability. - Negotiate with regulatory authorities to resolve questions/issues that arise prior to and during product submissions. - Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. - Interact directly with FDA and other major market regulatory agencies in support of product registration, approval, and commercialization. - Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. - Provide business and product information to international regulatory staffs to enable development of strategies and requirements for global commercialization. - Provide feedback and on-going support to product development teams to assure timely resolution to regulatory issues and questions. - Other duties as assigned.

The Salesforce Developer IT Commercial will have the ability to translate business needs into technical specifications, design and development solutions, test and deploy them into production. Must have a passion for working cross functionally and building solutions to support business process and data flows and a strength in solving platform issues with expert troubleshooting skills. This role will work closely with our Sales, Operations, IT, Marketing, Finance, and other groups as needed. Major Responsibilities include: - Provide software development support within a Salesforce environment including APEX, Visual Force Pages, Lightning Controls and Automations (Process Builder & Flow) - Develop and maintain OData API's to interface data between external applications/vendors and Salesforce Connect - Provide maintenance on existing systems while also architecting and developing new features based on business requirements - Design, implement and maintain solutions within Salesforce Health Cloud and Community Cloud - Create and maintain technical documentation surrounding data integrations and APIs - Provide Salesforce administration - Collaborate with business teams and product owners to gather requirements and develop innovative solutions

Systems Engineer, Medical Device, Redwood City, CA- Ensure the logical and systematic conversion of customer requirements and performance requirements into systems solutions that account for technical, cost and schedule constraints for RF communications systems and active implantable systems. Collaborate with cross-functional stakeholders to identify design inputs (user needs and system requirements). Evaluate technical, scheduling, and resource tradeoffs when generating requirements for project. Ensure requirements are correct, complete, unambiguous, and testable, and provide sufficient detail for tracing to subsystem and module level requirements. Document design inputs into requirements tracking system for tracking and traceability. Utilize IEC 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering. Perform human factors engineering across the product lifecycle including identification of customer user needs and use scenario, definition of use specifications (user profiles, user environments) and user interface requirements. Assist with generation of deliverables for compliance with IEC 60601, IEC 62366, IEC 62304, ISO 14708, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering, including working with external vendors as necessary. Investigate and define systems engineering requirements for new algorithms or features. Perform Risk management using risk analysis, FMEA, or ISO 14971. Perform engineering tasks including definition, verification, or product development of a system, and drive them to on-time, high quality completion. Perform hands-on system integration testing and troubleshooting of technical issues. Perform system level verification against requirements. Create test plans, procedures and reports, perform and analyze system setup, and conduct verification and validation activities. Hybrid work is permitted per employer’s discretion. (No agencies or phone calls please.) #LI-DNI  

- Owns transactions recording, records accuracy and corresponding reconciliation process for Costa Rica Site General Ledger, in both, Corporative and Statutory books. - Responsible for statutory Financial Statements preparation and all relations and reporting with governmental tax and compliance authorities. - Responsible for month end close process for Statutory books. - Other accounting tasks assigned as required, such as fixed assets, treasury, AP, AR, etc - Free Zone Status regulations, requirements and audits compliance. Work with other departments to develop and promote a culture for Free Zone requirements compliance.