The Systems Engineer III will play a key role in the development of a Class III implantable Neuromodulation system for pain management, working cross functionally to help define systems and ensure that all stakeholders are aligned, and user needs are met. In this role, you will be a highly productive member of the technical team to help make key and impactful decisions.
- Ensure the logical and systematic conversion of customer requirements and performance requirements into systems solutions that account for technical, cost and schedule constraints.
- Assist with investigation and definition of systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through clinical review and evaluation.
- Owns tasks within a larger effort such as definition, verification or product development of a system, and drives them to on-time, high quality completion.
- 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 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering, including working with external vendors as necessary.
- Assist with generation of cybersecurity deliverables for compliance with MDCG 2019-16, FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, and FDA Guidance Postmarket Management of Cybersecurity in Medical Devices.
- Performs hands-on system integration testing and troubleshooting of technical issues. Works with development team to identify root cause and viable resolutions for issues.
- Performs system level verification against requirements. Creates test plans, procedures and reports, performs and analyzes system set up, and conducts verification and validation activities.
- Provide technical guidance to teams of engineers for systems engineering activities and deliverables
- Assists with development of quality processes consistent with existing practice in collaboration with cross functional stakeholders.
- Other duties as assigned
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
You will be key in development of Nevro’s next generation Class III systems and accessories. Your passion is twofold: working in cutting-edge medical technology while significantly impacting lives. You are precise, obsessed about quality, and driven to make a difference with your EE talents.
- Develop the next generation of implantable neuromodulation systems and other accessories
(remotes, chargers, etc.).
- Design Electronic Circuits (Embedded Systems, Mixed Analog/Digital Circuits, Power Regulators, etc.)
- Responsible for Schematics Design and PCB Layout.
- Investigate and determine root cause of system failures.
- Advise the development of firmware for corresponding hardware.
- Design experiments to characterize hardware, devise test plans, interpret data and present reports.
- Contribute to the leadership and organization of work for a small team/project.
- Responsible for planning, developing, coordinating, and directing their own work, collaborating with other internal and external resources to be successful.
- Operates at the capacity of an expert in the field.
- Interface with external stakeholders as the primary point of contact and/or technical expert for one or more product areas.
- Proactively identify areas of developmental risk and communicate these to management
- Foster an environment of proactive cooperation and open communication.
- Guide contributions into final manufactured products.
- Assure contributions interface properly with all aspects of the system.
- Meet or exceed performance requirements by working closely with other product development team members.
- Contribute to the intellectual property base of the company via active communication of new concepts to management.
- Work in accordance with quality system procedures and actively enforce its objectives.
- Perform other duties as assigned.
The Senior Systems Engineer will play a key role in the development of a Class III implantable Neuromodulation system for pain management, working cross functionally to help define systems and ensure that all stakeholders are aligned, and user needs are met. In this role, you will be leading the technical team to make key and impactful decisions.
- Technical lead for system architecture and design of an implantable SCS system with wireless Bluetooth interfaces.
- Works with stakeholders, customers, and engineers to ensure the logical and systematic conversion of customer requirements and performance requirements into systems solutions that account for technical, cost and schedule constraints.
- Investigates and defines systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through clinical review and evaluation.
- Once requirements are defined with customers, speaks on their behalf to guide day-to-day engineering activities.
- Owns large efforts such as definition, verification or product development of a system, and drives them to on-time, high quality completion.
- 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.
- Generates deliverables for compliance with IEC 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering, including working with external vendors as necessary.
- Generates the cybersecurity deliverables for compliance with MDCG 2019-16, FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, and FDA Guidance Postmarket Management of Cybersecurity in Medical Devices.
- Leads and performs hands-on system integration testing and troubleshooting of technical issues. Works with development team to identify root cause and viable resolutions for issues.
- Leads system level verification against requirements. Creates test plans, procedures and reports, performs and analyzes system set up, and conducts verification and validation activities.
- Provide technical guidance to teams of engineers for systems engineering activities and deliverables
- Coordinates daily activities effectively across the systems engineering team during the design, implementation, and test phases.
- Provides status updates to the PMO on behalf of the systems engineering team.
- Develops quality processes consistent with existing practice in collaboration with cross functional stakeholders.
- Other duties as assigned
The Associate Sales Representative (ASR) supports achievement of sales revenue targets and helps to grow market share for a specified territory by promoting, selling and servicing NEVRO products.Practice good territory management in terms of organization, administration and expense planning. Control and train appropriate medical staff on products and procedures. This is a clinical sale with strong value added focus and an emphasis on improving patient care outcomes.Account responsibility and sales development goals established by the RSD in conjunction with the DSM.
- Responsible for specified target accounts provided by DSM and RSD.
- Provide forecast for targeted accounts with DSM guidance.
- Prospecting for new customers, driving lead follow-up, and positively positioning our products and services to existing and new clients in the region.
- Identify, establish and maintain productive working relationships with key decision makers, customers and their staff, administrative staff, etc.
- Provide clinical support for DSM (programming, reprogramming, educating clients and patients, case coverage, etc.).
- Build strong relationships with key clients.
- Train and educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using appropriate formats and platforms (e.g., slides, manuals, etc.) to keep customers abreast of new and existing products.
- Report on sales process, market conditions, and customer activities to sales leader.
- Utilize internal platforms to ensure flawless execution of product delivery to clients and patients.
- Plan, coordinate and execute local educational and sales events, with the support of other internal resources, intended to augment the business and help to deliver assigned sales goals.
- Other duties as assigned
The Firmware Engineer is a general software engineer with a specialty in embedded (firmware) development. The are expected to participate in research and product development activities ranging from product concept through transfer to manufacturing. This position will apply knowledge of engineering principles and practices for software development of implantable medical devices and accessories.
Role Requirements
- Develops embedded and PC-based software, which interact with devices such as an implantable stimulator.
- Development activities include requirements definition, design, implementation, and verification / validation.
- Debugging and analyzing device issues and field returns.
- Develops software in a regulated environment in accordance with internal operating procedures and external standards and regulations.
- Conducts cross-functional reviews of the software at appropriate times in the development cycle.
- With direction, determines and pursues courses of action necessary to obtain desired results.
- Applies technical principles, theories, and concepts, in addition to developing new principles and concepts towards the solution of complex technical problems and provides solutions which are innovative and ingenious.
- Proactively identifies areas of developmental risk and communicates these to the team accordingly.
- Works in accordance with quality system procedures and actively enforces its objectives.
- Other duties as assigned
The Application Engineer is a general software engineer with a specialty in PC-based development. The are expected to participate in research and product development activities ranging from product concept through transfer to manufacturing and deployment and upgrade of computers in the field. This position will apply knowledge of engineering principles and practices for software development of implantable medical devices and accessories.
Role Requirements
- Develops embedded and PC-based software, which interact with devices such as an implantable stimulator.
- Development activities include requirements definition, design, implementation, and verification / validation.
- Debugging and analyzing device issues and field returns.
- Develops software in a regulated environment in accordance with internal operating procedures and external standards and regulations.
- Conducts cross-functional reviews of the software at appropriate times in the development cycle.
- With direction, determines and pursues courses of action necessary to obtain desired results.
- Applies technical principles, theories, and concepts, in addition to developing new principles and concepts towards the solution of complex technical problems and provides solutions which are innovative and ingenious.
- Proactively identifies areas of developmental risk and communicates these to the team accordingly.
- Works in accordance with quality system procedures and actively enforces its objectives.
- Other duties as assigned
Integration Developer, Redwood City, CA - Analyze integration requirements, solution design, and ETL development. Analyze and review business requirement documents, Source Target Mappings, and complex data models. Deliver data integration solutions for Nevro’s large-scale enterprise systems. Build Data pipelines and perform end-to-end testing to maintain the data integrity of the systems. Design flexible, supportable, and extensible solutions. Analyze problem statements and respective data source systems to design and automate end-to-end business intelligence solutions. Design and develop transformation rules to support transaction databases. Work with Database components in Talend including Snowflake, SQL, ETQ, QAD, and Salesforce. Develop transformations with different file formats like JSON, XML, CSV, and Flat file. Write complex SQL code procedures. Apply data modeling methodologies and concepts to integration development. Present daily sales and revenue reports to executive management. Create a Tableau story containing Key Performance Indicators & Detailed Analysis. Design, build, and configure applications to meet business process and application requirements through business analysis requirements gathering sessions. Perform end-to-end development and testing of the Talend processes, including documenting technical data flows between operational systems. Perform development and architecture design experience with Talend. Proficient in functional knowledge of QAD, ETQ, & Salesforce. Build data engineering solutions for integrating CRM and Various systems like QAD, ETQ, Anaplan, Concur, and Snowflake Data Warehouse. Lead end-to-end Business Intelligence projects with Minimal guidance. Proficiency in Python. Experience in handling multiple clients simultaneously. Perform the data modeling necessary to support evolving data storage and processing needs. (No agencies or phone calls please.) #LI-DNI
Must possess 2 years of experience with a Master’s degree or 5 years of experience with a Bachelor’s degree in the following:
- Delivering data integration solutions for large-scale enterprise systems
- Writing complex SQL code procedures
- Data modeling methodologies and concepts
- Conducting business analysis requirements gathering sessions
Must possess 1 year of experience with - Database integration development using Talend Enterprise Data Management (including Snowflake, SQL, and Salesforce) and Talend Stitch
May work remotely within the area of intended employment at employer discretion
The District Sales Manager is responsible for the achievement of District sales targets for the company and manages all resources, including clinical support and field sales representatives. This includes overseeing and leading the identification of business opportunities, building and fostering client relationships, and ensuring the effective sales of NEVRO’s products to meet/exceed sales forecasts and goals. This position reports directly to the Regional Sales Director.
- Relationship-selling, partnering and managing accounts.
- Fiscal budgetary responsibility.
- Asset/inventory management.
- Initiate and evaluate corporate pricing agreements with customers to ensure competitive value of product line.
- Create business plan and ensure proper execution.
- Promote, sell and secure orders from existing and potential customers.
- Submit periodic reports detailing activities/sales volumes/training needs. Assist sales associates/clinical support in developing and selling to new accounts.
- Help ensure the success of sales/marketing plan and sales objectives through sales efforts directed towards sales associates and customers.
The Therapy Consultant is the primary clinical support who works with Nevro Sales Representatives to meet existing and potential clients (e.g., physicians, physician office groups at hospitals) and patients to identify their clinical goals and constraints related to patient needs. They also provide technical expertise, product demonstrations, installation and maintenance of company products.
- Promote company products to current and potential customers within a defined region by providing clinical education of implant procedures and support.
- Serve as primary resource for clinical support including, but not limited to: troubleshooting, programming, and patient follow-up for company products.
- Respond to customer needs regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical, research, marketing, technical support) to develop optimal solutions.
- Provide follow-up support to company sales staff and customer personnel by disseminating technical information on specific applications.
- Train and educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using appropriate formats and platforms (e.g., slides, manuals, etc.) to keep customers informed of new and existing products.
- Attend and oversee trials/procedures/implants in a clinical setting including labs and operation rooms of hospital accounts.
- Perform patient follow-up to assure customer and patient success with the implanted products.
- Develop and maintain business relationships with hospital personnel.
- Utilize internal platforms to ensure flawless execution of product delivery to clients and patients.
- Visit customers and patients in a clinical environment (hospitals, operating rooms, clinics, surgical centers).
- Communicate with Patients and Clients afterhours and on weekends as needed.
- Travel daily within territory.
- Other duties as assigned.
The District Sales Manager is responsible for the achievement of District sales targets for the company and manages all resources, including clinical support and field sales representatives. This includes overseeing and leading the identification of business opportunities, building and fostering client relationships, and ensuring the effective sales of NEVRO’s products to meet/exceed sales forecasts and goals. This position reports directly to the Regional Sales Director.
- Direct training, coaching and direction of sale(s) representative/clinical specialists.
- Relationship-selling, partnering and managing accounts.
- Fiscal budgetary responsibility.
- Asset/inventory management.
- Initiate and evaluate corporate pricing agreements with customers to ensure competitive value of product line.
- Create business plan and ensure proper execution.
- Promote, sell and secure orders from existing and potential customers.
- Submit periodic reports detailing activities/sales volumes/training needs. Assist sales associates/clinical support in developing and selling to new accounts.
- Help ensure the success of sales/marketing plan and sales objectives through sales efforts directed towards sales associates and customers.
As the Senior Manager, Strategic Growth & Innovation (upstream marketing), you will play a pivotal role in helping steer the organization toward its future objectives by supporting identified opportunities for expansion and innovation. Working closely with a cross-functional team from R&D, Clinical, Sales, Regulatory, and Downstream Marketing, you will contribute to the development and execution of strategic initiatives aimed at fostering sustainable growth and enhancing the organization's competitive edge. Your responsibilities will involve project management, researching market trends, and supporting innovative strategies to propel the organization forward in a dynamic and ever-evolving business landscape.
This position will report directly to the Senior Director, Strategic Growth & Innovation.
Key Responsibilities:
1. Product Development Coordination:
· Collaborate with cross-functional teams, including R&D, engineering, and regulatory affairs, to support product development initiatives from concept ideation to commercialization.
· Assist in coordinating project timelines, milestones, and deliverables to ensure alignment with business objectives and timelines.
2. Market Strategy Support:
· Assist in the development and execution of upstream marketing strategies, including product positioning, messaging, and segmentation strategies.
· Support downstream marketing in creating marketing collateral, presentations, and sales tools to communicate product value propositions to internal and external stakeholders.
3. Market Research & Analysis:
· Conduct comprehensive market analysis to identify emerging trends, customer preferences, and unmet needs within the target market.
· Utilize various methodologies, including surveys, focus groups, and data analysis, to gather insights.
4. Project Management:
· Manage multiple projects simultaneously, ensuring timely completion of deliverables and adherence to project timelines and budgets.
· Coordinate cross-functional teams and stakeholders to facilitate communication, collaboration, and decision-making throughout the project lifecycle.
5. Cross-Functional Collaboration:
· Work closely with internal stakeholders, including R&D, regulatory affairs, clinical affairs, sales, and marketing teams, to support collaborative efforts and alignment of objectives.
· Foster a culture of teamwork, communication, and accountability to drive collective success across departments.
6. Competitive Analysis:
· Monitor and analyze competitor activities, product launches, and market positioning strategies to identify strengths, weaknesses, and opportunities for differentiation.
· Provide insights and recommendations to the upstream marketing team to enhance competitive positioning and market share.
7. Regulatory Compliance Support:
· Assist in ensuring compliance with regulatory requirements and industry standards throughout the product development process.
8. Continuous Improvement:
· Identify opportunities for process improvement and optimization within the Strategic Growth & Innovation (upstream marketing) function, implementing best practices and innovative approaches to enhance efficiency and effectiveness.
· Stay abreast of industry trends, emerging technologies, and competitive developments to ensure the company remains at the forefront of innovation in the medical device industry.
This role offers an exciting opportunity to contribute to our organization's growth and success by supporting upstream marketing initiatives that drive product innovation and commercialization. The Senior Manager will play a critical role in assisting the upstream marketing team in identifying market opportunities, gathering customer insights, and executing strategic initiatives to bring innovative medical devices to market.
#LI-SO1
The Therapy Consultant is the primary clinical support who works with Nevro Sales Representatives to meet existing and potential clients (e.g., physicians, physician office groups at hospitals) and patients to identify their clinical goals and constraints related to patient needs. They also provide technical expertise, product demonstrations, installation and maintenance of company products.
- Promote company products to current and potential customers within a defined region by providing clinical education of implant procedures and support.
- Serve as primary resource for clinical support including, but not limited to: troubleshooting, programming, and patient follow-up for company products.
- Respond to customer needs regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical, research, marketing, technical support) to develop optimal solutions.
- Provide follow-up support to company sales staff and customer personnel by disseminating technical information on specific applications.
- Train and educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using appropriate formats and platforms (e.g., slides, manuals, etc.) to keep customers informed of new and existing products.
- Attend and oversee trials/procedures/implants in a clinical setting including labs and operation rooms of hospital accounts.
- Perform patient follow-up to assure customer and patient success with the implanted products.
- Develop and maintain business relationships with hospital personnel.
- Utilize internal platforms to ensure flawless execution of product delivery to clients and patients.
- Visit customers and patients in a clinical environment (hospitals, operating rooms, clinics, surgical centers).
- Communicate with Patients and Clients afterhours and on weekends as needed.
- Travel daily within territory.
- Other duties as assigned.
* Bilingual Spanish speaking skills are highly preferred for this position.
The District Sales Manager is responsible for the achievement of District sales targets for the company and manages all resources, including clinical support and field sales representatives. This includes overseeing and leading the identification of business opportunities, building and fostering client relationships, and ensuring the effective sales of NEVRO’s products to meet/exceed sales forecasts and goals. This position reports directly to the Regional Sales Director.
- Relationship-selling, partnering and managing accounts.
- Fiscal budgetary responsibility.
- Asset/inventory management.
- Initiate and evaluate corporate pricing agreements with customers to ensure competitive value of product line.
- Create business plan and ensure proper execution.
- Promote, sell and secure orders from existing and potential customers.
- Submit periodic reports detailing activities/sales volumes/training needs. Assist sales associates/clinical support in developing and selling to new accounts.
- Help ensure the success of sales/marketing plan and sales objectives through sales efforts directed towards sales associates and customers.
The Sales Support Specialist serves as the go-to person for help, training, and support for the team members in the Sales Area in which they are assigned. They will address questions and issues from their sales team and provide insight and remedial training on systems and processes. The Sales Support Specialist identifies root cause and system/process inefficiencies and works cross functionally to seek solutions to resolve the issues. This role reports to the Manager, Sales Operations.
· Works directly with the sales team to troubleshoot and identify common problems, resolve support tickets, and work with internal teams to assist with other field-based needs
· Applies critical thinking skills to identify root cause and prevent issues by creating solutions where possible
· Has common process knowledge across all commercial business processes to determine point of contact for issues – i.e. Sales Operations, SFDC, Product Support, IT, NevroCare, Therapy Excellence, Legal, and Pricing
· Acts as primary point-of-contact when issues are assigned to other teams to ensure issues are addressed timely and requests education as-needed when knowledge gaps are identified
· Works with a high sense of urgency and positive attitude
· Participates in new system end user testing and validation activities
· Maintains professional and technical knowledge
· Other duties as assigned
The Sales Support Specialist serves as the go-to person for help, training, and support for the team members in the Sales Area in which they are assigned. They will address questions and issues from their sales team and provide insight and remedial training on systems and processes. The Sales Support Specialist identifies root cause and system/process inefficiencies and works cross functionally to seek solutions to resolve the issues. This role reports to the Manager, Sales Operations.
· Works directly with the sales team to troubleshoot and identify common problems, resolve support tickets, and work with internal teams to assist with other field-based needs
· Applies critical thinking skills to identify root cause and prevent issues by creating solutions where possible
· Has common process knowledge across all commercial business processes to determine point of contact for issues – i.e. Sales Operations, SFDC, Product Support, IT, NevroCare, Therapy Excellence, Legal, and Pricing
· Acts as primary point-of-contact when issues are assigned to other teams to ensure issues are addressed timely and requests education as-needed when knowledge gaps are identified
· Works with a high sense of urgency and positive attitude
· Participates in new system end user testing and validation activities
· Maintains professional and technical knowledge
· Other duties as assigned
The Sales Support Specialist serves as the go-to person for help, training, and support for the team members in the Sales Area in which they are assigned. They will address questions and issues from their sales team and provide insight and remedial training on systems and processes. The Sales Support Specialist identifies root cause and system/process inefficiencies and works cross functionally to seek solutions to resolve the issues. This role reports to the Manager, Sales Operations.
· Works directly with the sales team to troubleshoot and identify common problems, resolve support tickets, and work with internal teams to assist with other field-based needs
· Applies critical thinking skills to identify root cause and prevent issues by creating solutions where possible
· Has common process knowledge across all commercial business processes to determine point of contact for issues – i.e. Sales Operations, SFDC, Product Support, IT, NevroCare, Therapy Excellence, Legal, and Pricing
· Acts as primary point-of-contact when issues are assigned to other teams to ensure issues are addressed timely and requests education as-needed when knowledge gaps are identified
· Works with a high sense of urgency and positive attitude
· Participates in new system end user testing and validation activities
· Maintains professional and technical knowledge
· Other duties as assigned
The District Sales Manager is responsible for the achievement of District sales targets for the company and manages all resources, including clinical support and field sales representatives. This includes overseeing and leading the identification of business opportunities, building and fostering client relationships, and ensuring the effective sales of NEVRO’s products to meet/exceed sales forecasts and goals. This position reports directly to the Regional Sales Director.
- Relationship-selling, partnering and managing accounts.
- Fiscal budgetary responsibility.
- Asset/inventory management.
- Initiate and evaluate corporate pricing agreements with customers to ensure competitive value of product line.
- Create business plan and ensure proper execution.
- Promote, sell and secure orders from existing and potential customers.
- Submit periodic reports detailing activities/sales volumes/training needs. Assist sales associates/clinical support in developing and selling to new accounts.
- Help ensure the success of sales/marketing plan and sales objectives through sales efforts directed towards sales associates and customers.
We are looking for a Cloud Security Engineer (Senior or Principal depending on experience) in our Security team whose responsibility is to protect Nevro’s AWS cloud infrastructure that covers the product and internal cloud environments. The ideal candidate is an expert in AWS Cloud Security Design, Architecture, and Implementation and is hands-on in driving implementation of infrastructure as code using (Terraform). Main responsibilities are:
· Responsible for protecting Nevro’s AWS infrastructure and applications.
· Partner with Developers, IT, DevOps, and security champions to secure the AWS environment.
· Drive the adoption of risk-based, contextual and data driven vulnerability management.
· Prevent cloud misconfigurations and secure the deployment process for containers, images and serverless workloads.
· Drive the implementation of AWS Well Architected Framework from a security standpoint.
· Create visibility, identify, and defend from threats.
· Develop strategies to increase Cloud Security knowledge throughout the enterprise and develop and mentor engineers in IT, Developers, DevOps and security teams.
· Lead the management and creation of cloud Security policy and procedures as it relates to cloud security Architecture.
#LI-SO1
This is an onsite role for 5 days/week related to daily incoming inspection and quality control for orthopedic implant and reusable instruments. Responsible for contributing, supporting, and maintaining the Receiving Inspection processes within the requirements of FDA’s Quality System Regulations (QSR) and ISO 13485. This position is based in King of Prussia, PA location and will solely focus on S.I. joint implants and associated instruments.
Applying knowledge of Inspection and GMP requirements daily, the duties and responsibilities for this position include, but are not limited to, the following:
- The QE Tech Performs inspections for the Receiving Inspection (RI) area(s) following applicable procedures.
- Responsible for the correct handling of the corresponding fixtures and equipments.
- Correct use of quality inspection records following GMP requirements.
- Ensure consistency and quality of records by editing and proofreading all documentation prior to handling it to the documentation center for storage.
- Maintain and archive documents in an organized and retrievable state (manual or electronic) for compliance with procedures, regulations, and standards.
- Safekeeping all quality records for the RI.
- Schedule periodic document reviews to ensure documents are compliant with Nevro requirements and processes as well as external regulations.
- Communicates corrections and improvement opportunities for departmental SOP, WI, Drawings, and forms and updates them as required.
- Responsible for ensuring timely release of components by executing, reviewing, and approving Lot History Records (LHRs) and ERP transactions per internal requirements.
- Responsible for the control of nonconforming material (identification, segregation)
- Interface with cross functional team to ensure internal and external compliance requirements are followed and implemented per requirements.
- Labelling and segregation of components inspected on the receiving inspection area.
- Notify cross functional departments including Operations, Supply Chain and Quality on component dispositions and/or material holds.
- Managing component disposition and queries.
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communication and resolving quality system issues.
- Support with External Audits activities when required and as directed.
- Perform other duties as assigned.
- Support activities related to Kaizen and Audit preparations.
