Project Management Engineer Salary in Redwood City, CA

Quality Engineer IIIJob LocationsUS-CA-Redwood CityReq No.2020-6485CategoryITTypeRegular Full-TimeSummary of Major ResponsibilitiesAs a member of the Quality Engineering (QE) team in the IT Software Engineering department, the QE will play a key role in contributing to the successful delivery of products from conception to go-live with emphasis on software quality for an exceptional customer experience. This role will be involved in all phases of system development, including requirements, analysis, design, development, testing, and support.  The ideal candidate must demonstrate the ability to understand system architecture, design, implementation and possess the ability to succinctly develop the strategy to deliver high-quality results in a time-sensitive environment. Essential Duties and ResponsibilitiesParticipate in requirements, design, and review meetings.Execute test strategy, test plan, and risk assessment leading to successful implementation and timely project completion.Create, maintain, and execute test cases/test scripts (manual/automated) for the user stories developed to build new features and product functionality.Develop test scripts to verify workflow functionality and REST API’s.Create and execute SQL queries to verify data integrity.Report, track, and escalate anomalies discovered during testing and ensure closure on the issues.Collaborate with cross-functional teams to ensure timely and effective testing, as part of a regular release schedule.Ability to work proactively, independently, or as part of a team on multiple tasks and projects, and quickly learn new technologies.Strong organizational, problem-solving, and analytical skills.Excellent written and verbal communication; inclusive of technical documentation skills.Ability to integrate and apply feedback in a professional manner.Ability to prioritize and drive to results with a high emphasis on quality.Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Regular and reliable attendance. Ability and means to travel between Redwood City locations.Ability to travel 5% of working time away from work location, may include overnight/weekend travel.QualificationsMinimum QualificationsBachelor’s Degree in Computer Science or related field; or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelor’s degree.5+ years of experience with web-based enterprise application testing and technical/domain expertise in CRM solutions.2+ years of experience using tools like SOAPUI, JMeter, Selenium, TestNG.2+ years of experience working in an Agile/Scrum-like environment.Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.Preferred QualificationsExperience testing web services and/or REST API using JSON/XML.Working knowledge of CI/CD framework.Knowledge of SDLC processes.Experience in SaaS, SaMD, or Cloud environments.Experience in SOA environments. Experience in working in a regulated environment (e.g., SOX, HIPAA, CLIA, GCP, and/or FDA). #LI-SS1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Technical Services Engineer II - Redwood City, CAJob LocationsUS-CA-Redwood CityReq No.2020-6742CategoryManufacturing Operations, Facilities & SecurityTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Technical Service Engineer II is the escalation point for instrument support and automation processes used in Exact Sciences clinical laboratories. This individual is responsible for providing outstanding technical support for both custom and off the shelf complex automation including liquid handlers, six-axis robots, digital pathology instruments and more. The Technical Service Engineer II has exceptional mechanical aptitude, along with the customer first mentality. This position supports Exact Sciences Redwood City, CA facility primarily.  Essential Duties and ResponsibilitiesReceives and documents incoming customer escalations.Works directly with the customer to further understand their escalation issues. Directly troubleshoots issues, leveraging their own knowledge, the original manufacturer’s support, and other subject matter experts when appropriate.Provides written documentation for the resolution of escalations.Advances best practice service procedures through proper channels for customer release. Provide guidance and advice to the customer’s service department.Works on individual assignments and participates in team projects appropriate to meet department and project objectives. Conducts experiments to reproduce customer issues and find root cause of failure. Prepares summary reports for failure modes for investigative purposes.Creates training materials that aid in transferring knowledge of new/modified processes and equipment.Schedules and conducts train the trainer classes to transfer new equipment processes to the customer.Maintains and continuously develops personal knowledge and expertise related to the service of complex clinical laboratory equipment.Actively create and maintain great working relationship with customer, service department, internal SMEs.Provide routine and professional communication to customer and internal SMEs both written and orally.Highly reliable, self-starter; can be counted on to complete assignments and work independently.Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.Support and comply with the company’s Quality Management System policies and procedures. Regular and reliable attendance. Ability to work Monday through Friday typical business hours.Ability to lift up to 25 pounds for approximately 10% of a typical working day.Ability to work seated for approximately 70% of a typical working day. Ability to work standing for approximately 30% of a typical working day. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.Ability to comply with any applicable personal protective equipment requirements.QualificationsMinimum QualificationsBachelor’s degree in engineering or related field; or a High School Degree/General Education Diploma and four years of relevant experience in lieu of a Bachelor’s degree.7+ years of hands-on experience in equipment maintenance, such as mechanical technical support, field support, or engineering.2+ years of experience utilizing statistical and mathematical methods.Proficient in Microsoft Office to include Excel macros and pivot table, track changes, able to create and modify spreadsheets, create formulas, etc. Basic computer skills to include Internet navigation, Email usage, and word processing.Demonstrated ability to perform the Essential Duties of the position with or without accommodation.Preferred QualificationsReside near the Redwood City, CA.Coursework or professional working knowledge of SQL queries.3+ years of experience working in a technical support function role.3+ years of experience servicing and maintaining liquid handler lab equipment.Experience in a Medical Device field working in a regulated environment, e.g., ISO 13485, FDA GMP, or USDA.#LI-BB1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Senior Systems Engineer IIJob LocationsUS-CA-Redwood CityReq No.2020-6728CategoryClinical Lab OperationsTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Mission of the Precision Oncology Business Unit of Exact Sciences is to transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics, both as in-vitro diagnostic (IVD) devices and as Laboratory Developed Tests (LDTs) conducted in our Redwood City Clinical Laboratory. Reporting to the Director of Systems Engineering, the Senior Device and Process Systems Engineer will provide technical expertise, vision, and leadership to drive continuous improvement of our state-of-the-art diagnostic tests for cancer patients. The Senior Device and Process Systems Engineer will lead projects to innovate, analyze, design, and implement improved business processes and laboratory workflows for diagnostic tests conducted in our Clinical Laboratory. Beginning with analysis of the business process requirements, these process design and integration efforts will encompass the generation and collection of requirements, design, and architecture, incorporation of applicable automation technologies, integration of multiple subsystems, and end-to-end testing.  Representing Lab Operations, the successful candidate will also be a key member on project teams developing new IVD devices and laboratory automations, ensuring their efficient and effective transfer into production, and will also contribute to ongoing improvements of existing commercialized processes and products.  It is critical that the candidate has strong expertise in medical device quality standards and regulations, including ISO13485, ISO14971, 21CFR Part 820, and experience in the operationalization of new diagnostic and/or medical devices. Demonstrated ability to effectively execute multiple projects simultaneously with Lean Methodology is required. Experience with business process analysis and design is required, ideally including experience with order to revenue processes.Essential Duties and ResponsibilitiesParticipate in or lead cross-functional process development teams to innovate, plan, develop, validate, and implement robust and scalable laboratory and business processes. Participate in new product development programs, operationalizing production processes including manufacturing, product distribution, and order to revenue workflows.Collaborate with internal Manufacturing, Supply Chain, R&D, and QA teams, and with  third party technology partners, contract IVD manufacturers and logistics partners as needed to create, scale, and validate supply chain, manufacturing, and distribution processes and infrastructure.Translate business needs and customer requirements into clear, well-vetted requirements, and conduct and guide requirement tracing, architecture design and other key Systems Engineering methodologies for new production processes.Incorporate business strategy into project scope, plan, and design that may involve multiple phased releases of the product or process.Provide leadership in incorporating risk management into project planning and execution, conducting, facilitating, and reviewing risk assessments required in development and revision of production processes. Systemize learning and best practices into practical procedures. Advise and present options, recommendations, and plans, and status to senior management on projects and associated issues and risks.Apply Robust Design / Design for Six Sigma principles to development of production processes.Lead complex problem solving in design and support of production processes and associated processing equipment.Provide expertise and leadership in Design of Experiments (DOE), failure analysis, root cause analysis, and associated statistical methods. Ability to assist and mentor junior Systems Engineer members. Ability to effectively lead and participate in multidisciplinary project teams, providing technical leadership and guidance to team members.Superb written and oral communication skills, and excellence in communicating and collaborating with colleagues, customers, and external collaborators from a wide variety of scientific, engineering, operational, and regulatory disciplines at many different levels. Deal with ambiguity and deliver simple engineering solutions to complex problems. Apply understanding of complex end-user applications, collecting and clearly documenting user needs. Ability to methodically break down complex applications into simpler elemental constituents and formulate clear and concise requirements to meet end user needs. Perform work with minimal direction, exercising sound judgement in defining technical objectives of assignments.Apply critical thinking skills to judiciously plan and prioritize project activities for maximum leverage and impact. Apply leadership skills to align colleagues and partners around a vision, a plan to achieve it, and the execution of this plan. Exhibit commitment to quality in the development, testing, and implementation of systems and processes to be used in diagnostic tests. Ability to integrate and apply feedback in a professional manner. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.Support and comply with the company’s Quality Management System policies and procedures.Regular and reliable attendance.Ability to work designated schedule.Ability to work nights and/or weekends, as needed.Use of computer, and or telephone for long periods of time may be necessary.Considerable periods of time may be spent concentrating and or analyzing data.Some lifting (greater than 25 pounds) may be necessary.May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.Ability and means to travel between Red Wood City locations.Ability to travel 10% of working time away from work location, may include overnight/weekend travel.QualificationsMinimum QualificationsBachelor’s degree in Engineering or related field; or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelor’s degree.10 + years of IVD, laboratory automation, and/or medical device experience.Proficient familiarity with the principles and tools for Innovation Processes (i.e., TRIZ), Lean Design, Robust Design, Design for Six Sigma, Systems Engineering, DOE, VOC, and Design for Reliability, and related methodologies.Demonstrated ability to perform the Essential Duties of the position with or without accommodation.Authorization to work in the United States without sponsorship.Preferred QualificationsAdvanced Engineering degree. Experience with development of business workflows using enterprise software systems for clinical diagnostic applications.Experience in developing diagnostic test in a highly regulated environment (i.e., CLIA, FDA, ISO13485 etc.).Experience with requirements management tools (i.e., Jama, Aligned Elements, DOORS, etc.).Six Sigma Black Belt.Experience in project management.#LI-LA1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Database Integration EngineerJob LocationsUS-CA-Redwood CityReq No.2020-5994CategoryITTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Database Integration Engineer I will be a key member of the Infrastructure Engineering and Operations team at Exact Sciences, supporting data Integration, data modelling, data cleansing, and data migration. The successful candidate will have extensive experience in collecting business and user requirements, developing functional specifications, and integrating data to engineer automated production solutions for robustness, reliability, and operational simplicity.Essential Duties and ResponsibilitiesActs as a technical resource to our business partners in all phases of the development and implementation process; assist with incident and problem resolution as needed.Works with Analysts and Business Users to translate functional specifications into technical designs for implementation and deployment.Studies data sources by interviewing users; defining, analyzing, and validating data objects; identifying the relationship among data objects.Plans data integration process by developing common definitions of sourced data; designing common keys in physical data structure; establishing data integration specifications; examining data applications; examining data models and data warehouse schema; determining best-fit data interchange methods; assessing middleware tools for data integration, transformation, and routing; developing project scope and specifications; identifying factors that negatively impact integration; forecasting resource requirements; establishing delivery timetables.Improves data integration by designing and evaluating new data interchange formats; improving physical design; rewriting data policy, standards, and procedures.Provide problem-solving expertise and complex analysis of data to develop business intelligence integration designs.Build extensible data acquisition and integration solutions to meet the functional and non-functional requirements of the business.Design, develop, and deploy data movements using SQL Server Integration Services, TSQL and Stored Procedures.Collaborate with business analysts, subject matter experts, and other team members to determine data extraction and transformation requirements.Conducts integration testing and maintains all integrations/DB systems.Assures adherence to change management processes and security standards.Follow data standards, resolve data issues, complete unit testing, and system documentation for data migration processes.Provide development, QA, and production support to troubleshoot day-to-day data related issues.Establish and maintain policies and procedures for Data Registration\Data Architecture.Engages in vendor relationship management.Setup and manage tools for database monitoring, diagnostics, and performance optimization for the data migration efforts.Provide database infrastructure and architecture recommendations to admins supporting tactical and strategic business needs.Engages in developing cloud strategies.Work with IT operations teams to troubleshoot ETL and MDM issues and optimize the database server environments.Partner with application and operations teams to establish and maintain standard operating procedures for data cleansing, data modelling, and data migration.Engages in physical infrastructure maintenance; coordinates work activities with server and network operations team.Works closely with SFDC and NetSuite admins to build automated workflows to ease admin activities.Knowledge in installation and configuration of database clusters.Ability to work effectively in a team-oriented environment with strong interpersonal and communication skills.Results and deadline driven; must be willing to do whatever it takes to meet deadlines.Solid analytical, problem solving, and trouble-shooting skills.Excellent customer service skills and attention to detail.Ability to communicate and negotiate with both technical and non-technical colleagues and stakeholders.Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule.Ability to work nights and/or weekends.Ability to lift up to 25 pounds for approximately 1% of a typical working day.Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 100% of a typical working day.QualificationsMinimum QualificationsBachelor’s degree in Management Information Systems, Computer Sciences, or related fields.5+ years of experience with SQL Server Integration Services (SSIS).5+ years of experience in T-SQL and writing efficient and highly optimized SQL queries.4+ years of complete data analysis/mapping and data profiling.4+ years of experience setting up SQL Server 2012/2016/2017/2019 features for large database environments and geographically distributed production data centers.2+ years of experience in database modelling and data design of OLTP and OLAP applications. 2+ years of experience with retrieving and loading data from/to Salesforce and NetSuite platforms.  2+ years of experience with Agile methodologies.Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.Preferred QualificationsMicrosoft SQL Server DBA Certification. Experience with PostgreSQL.  #LI-AL1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Senior Laboratory Automation EngineerJob LocationsUS-CA-Redwood CityReq No.2020-6733CategoryClinical Lab OperationsTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Mission of the Precision Oncology Business Unit of Exact Sciences is to transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics, both as in-vitro diagnostic (IVD) devices and as Laboratory Developed Tests (LDTs) conducted in our Redwood City Clinical Laboratory. The Senior Laboratory Automation Engineer will provide technical expertise to drive continuous improvement of our state-of-the-art diagnostic tests for cancer patients. The Process Engineering team is a multidisciplinary group of engineers with backgrounds in mechanical, electrical, software, and process engineering.  The Senior Laboratory Automation Engineer work will focus on designing, building, and optimizing integrated laboratory automation systems. The process engineering team has direct involvement throughout the lifecycle of our automation development; including design, build, test, launch, and continuous improvement. The successful candidate will be a key member on project teams developing integrated systems laboratory automation, ensuring their efficient and effective transfer into production, and will also contribute to ongoing improvements of existing commercialized processes and products. Essential Duties and ResponsibilitiesDesign and document new integrated robotic work cells with laboratory automation equipment; including selection and specification of robotic integration, software, motion control, liquid handling, and analytical components.Build and test integrated robotic work cells.Translate business needs and customer requirements into architecture design and other key Systems Engineering methodologies for new production processes. Evaluate and recommend engineering changes to existing devices and equipment in order to improve throughput, reliability, serviceability, and decrease cost.Manage documentation, suppliers, and contract manufacturers.Participate in or lead cross-functional process development teams to innovate, plan, develop, validate, and implement robust and scalable laboratory automation.Advise and present options, recommendations, plans, and status to senior management on projects and associated issues and risks.Provide expertise and leadership in Design of Experiments (DOE), failure analysis, and root cause analysis.Ability to assist and mentor junior Process Engineering members. Ability to perform work with minimal direction, exercising sound judgement in defining technical objectives of assignments.Exhibit commitment to quality in the development, testing, and implementation of systems to be used in diagnostic tests.Strong analytical and problem-solving skills.Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.Support and comply with the company’s Quality Management System policies and procedures.Regular and reliable attendance.Ability to work designated schedule.Considerable periods of time may be spent concentrating and or analyzing data. Some lifting (greater than 25 pounds) may be necessary.May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.Ability and means to travel between Redwood City locations.Ability to travel 10% of working time away from work location, may include overnight/weekend travel.QualificationsMinimum QualificationsBachelor's degree Life Science, Scientific, Mechanical, Electrical, Biomedical Engineering, Engineering, or a related field.6+ years of experience with integrated systems laboratory automation, industrial system design, or related field.2+ years of experience with liquid handling instrument script writing and scheduler software programming.Demonstrated ability with system integration or factory automation in a regulated environment.Demonstrated ability in selecting and working with external suppliers and contract manufacturers.Demonstrated ability in integrating industrial articulated and SCARA robots.Demonstrated ability to perform the essential duties of the position with or without accommodation.Authorization to work in the United States without sponsorship.Preferred QualificationsMaster's Degree in Mechanical, Electrical, Biomedical Engineering, or a related field.Experience with Python and/or SolidWorks.Experience in developing diagnostic test in a highly regulated environment (e.g., CLIA, FDA, ISO13485, etc.).Experience in project management.#LI-LA1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Principal Software EngineerUS-CA-Redwood City, RemoteJob ID: 2024-4432Type: Regular Full-Time# of Openings: 1Category: Research & DevelopmentUS-CA-Redwood City, RemoteOverviewLead the development of major features and architectural enhancements for the Nevro R&D Care Team Applications group, primarily for web services and web applications using Microsoft .Net Core, React, Terraform, and other technologies. Activities include:Working with the cross-functional teams to define software requirements.Designing data models, data flows, software components, and (as needed to extend existing implementations) cloud infrastructure architecture.Implementation of software and cloud infrastructure in AWS, Confluent Cloud, and others.Ensuring features are testable using automated test tooling.Implementing unit testing and/or performing manual testing for featuresDevelop software in a regulated environment in accordance with internal operating procedures and external standards and regulations. Proactively identify areas of developmental risk for projects or features and communicate these to management accordingly.Work closely with other product development teams: ensure that their products will interface as required with the Care Team Application’s products and overall system requirements are met.Work in accordance with quality system procedures and actively enforce its objectives.Contribute to the intellectual property base of the Company via active communication of new concepts to Management.Lead continuous improvement of our products, platforms, and practices:Define and document software development best practices and ensure adherence through code reviews and training sessions as needed.Enhance our SDLC to reduce toil or improve product quality. Continuously contribute to platform reliability, security, monitoring, logging.ResponsibilitiesB.S. in Computer Science, or similar degree.A minimum of 8+ years’ experience designing, architecting, and implementing web services and/or web applicationsQualificationsThe candidate should be and expert in the Microsoft.Net stack for web service implementations.The candidate should have extensive knowledge of production website operational concerns.The candidate should have a strong understanding of synchronous and asynchronous messaging patterns in a web services or big data context.It is highly preferred that this candidate has experience in implantable medical device development.Significantly self-directed. Determines and pursues courses of action necessary to obtain desired results.Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements is also preferred.Experience related to integrations into IoT or big data systems is preferable.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, disability, age or other characteristics protected by laws.PI238658386

Research Engineer IIIUS-CA-Redwood CityJob ID: 2024-4453Type: Regular Full-Time# of Openings: 1Category: Research & DevelopmentHQOverviewThe Research Engineer is responsible for investigating and implementing the technical and clinical requirements of the Product Research and Emerging Clinical Indications team. Under the direction of the senior members of the team, the research engineer will also research and investigate disruptive technical and clinical opportunities including developing clinical models of efficacy. He/she will be responsible for the tactical implementation of the program and projects within the team.Assists in the investigate novel, disruptive technologies, and clinical therapiesAssists in the exploration and evaluation of external technical and clinical opportunities and performing assessments, recommendations and technical due diligenceWorks closely with other team members in designing experimental protocols, as well as the conducting and monitoring these research projects, and interpretation of resultsParticipates in the development and writing of integrated reports and preparation of presentations and manuscripts of scientific meetings and technical journalsParticipates in design and writing of protocols, case report forms and informed consent forms for clinical studiesPerforms a variety of analysis in the collection, verification, analysis, documentation and interpretation of research dataEvaluates and interprets collected data, and prepares presentations, reports and analyses describing progress, trends, and recommendations or conclusionsIdentify, assess, recommend, and integrate novel technologies and/or clinical therapiesConduct descriptive and exploratory analysis of technical and clinical data Define statistical tests and methods for both evaluating and generating statistical hypothesesWork cross-functionally (e.g., business development, engineering, marketing, clinical affairs, quality, and legal) as needed to assess potential opportunities Other duties as assigned. ResponsibilitiesMaster’s or Ph.D degree in biomedical and/or electrical engineering required; an M.D. or advanced degree in a technical field and/or MBA preferred5+ years experience in the medical fieldEquivalent work experience may be substituted for education requirement.QualificationsDemonstrated ability to deliver on milestone-based programs and projectsDemonstrated understanding of medical technologies and clinical therapiesDemonstrated understanding of quality management systems Demonstrated understanding of regulatory processed and policies Demonstrated knowledge and understanding of human physiology and anatomyDemonstrated knowledge and understanding of human neurophysiology and neuroanatomyDemonstrated ability to implement technical and clinical solutionsDemonstrated experience with observational studies and patient reported outcomes Demonstrated astuteness in identifying and understanding meaningful intellectual propertyDemonstrated interpersonal and communication skillsNevro 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, disability, age or other characteristics protected by laws.PI239191391

Job Title: Mechanical Engineer and Project ManagerWe are looking for a driven and organized Mechanical Engineer / Project Manager who is familiar with design, drawings, BOM, and manufacturing of parts, and has experience with operations, finances & budgeting, creating schedules and tracking milestones. The candidate would work with a group of design engineers to order parts, manage suppliers and machine shops, manage schedules, budgets and technical deliverables for each project. As a small company, the candidate would also be heavily involved in the daily operations and finances of the company such as accounts payable, generating PO's and invoices, working with our bookkeeper, and creating project proposals and customer quotations. This is a full-time on-site position with some flexibility, please submit your resume and a cover letter to [email protected] and Qualifications:background in Design, BOM, Drawings and Machining cycles.in Project Management for hardware development: meeting, action items, organizing and tracking issues and milestones, presentations & customer proposals.in Procurement, generating PO's, working with Suppliers, Machine shops, and Customers.in finance and budgeting, and interested in learning small company business operations.Roles and Responsibilities:Mechanical Engineering Project Management:with mechanical engineers to develop manufacturing project plans (machine shop and supplier quotations, procurement, assembly, customer proposals, schedule updates, rework and delivery).engineering meetings with meeting agenda, take meeting notes, assign and track clear action items, update project schedule, track milestones & deliverables.responsibility for timely execution of manufacturing projects: from customer engagement to ordering, cleaning, building, debugging of assembly issues, and delivery.with Customer to develop production project plans & manage customer meetings and develop and track quotations, project proposals and deliverables and milestones.Procurement and Supply Chain Management:and tracking of parts, engaging with suppliers, and updating schedules.Excel Bill of Material (BOM), collaborate with engineers to create & track action items.weekly pickup/delivery plans, coordinate machine shop visits, plan UHV cleaning cyclestimely project execution by overseeing material handling and project logistics.Business Operations:quotations & project plans, customer proposals, organize and track accounts payable and accounts receivable, pay vendors and contractors, work with company bookkeeper.in learning about small company operations - QuickBooks, bookkeeping, etc.between Customers, Engineers, and Suppliers -Infrastructure: Manage Class 100 Cleanroom, SuppliesAdditional Requirements:responsible, and organized with a proactive approach to problem-solving.and able to find solutions independently and working as part of a larger teamto detail and a commitment to delivering high-quality work.and motivated in a long-term career in project and operations management.About the Company: Applied Precision Design is a small boutique engineering firm that builds custom mechanical & optical assemblies for Research and Development in various industries such as Semiconductors, Biomedical Imaging, etc. Our mission is to support innovative R&D projects that are meaningful and important for the world. Our office is in downtown Redwood City, CA in a fun and urban setting one block from Caltrain. As a small company we offer a kind, fun, and flexible work environment while taking pride in producing high quality work. Key Words: Mechanical Engineering, Project Management, Design, Manufacturing, Prototyping, Bill of Materials BOM, Procurement, Supply Chain Manager, Manager, CAD, Drawings, Schedule, Budgets, Finances, Business Operations, Invoices, Proposals, Quotations

Systems Engineer IIIUS-CA-Redwood CityJob ID: 2024-4461Type: Regular Full-TimeCategory: Research & DevelopmentHQOverviewThe 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 deliverablesAssists with development of quality processes consistent with existing practice in collaboration with cross functional stakeholders. Other duties as assignedResponsibilitiesBachelor’s degree in Software Engineering, Computer Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or equivalent degree/major required. Years of experience may be substituted for the degree requirement.Bachelor’s degree with 5 years, or Master’s degree with 3 years experience with development or verification in the medical device industry (Class III medical device experience preferred).QualificationsExperience with development in a regulated industry such as medical device, defense, or automotive.Experience in Systems Engineering as related to stakeholder needs definition, creation of use case workflows, requirements definition and decomposition, functional architecture, and system design.Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports.Experience working on multiple projects in a deadline driven environment.Experience with RF communications systems is desirable.Ability to generate buy-in from stakeholders to solutions for both technical and non-technical issues.Ability and willingness to make sound decisions potentially with high impact in a timely manner.Ability to provide creativity while solving complex problems without known solutions. Outstanding communication and presentation skills (written and verbal) to all levels of an organization.Experience interfacing with Software Development, Mechanical, Electrical, Operations, Quality and Regulatory Usability engineering (human factors) experience strongly desired.Risk management experience strongly desired.Cybersecurity in medical devices experience strongly desired.Project management skills including planning and estimation of tasks, milestones, resources, and budget desired.Willing to travel up to 10% as neededNevro 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, disability, age or other characteristics protected by laws.PI240040172

Senior Systems EngineerUS-CA-Redwood CityJob ID: 2024-4462Type: Regular Full-TimeCategory: Research & DevelopmentHQOverviewThe 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 deliverablesCoordinates 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 assignedResponsibilitiesBachelor’s degree in Software Engineering, Computer Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or equivalent degree/major required. Years of experience may be substituted for the degree requirement.Bachelor’s degree with 8 years, Master’s degree with 6 years, or PhD with 3 years of related experience with development or verification in the medical device industry (Class III medical device experience preferred).Mostly self-directed. Determines and pursues courses of action necessary to obtain desired results. (Recommendation of assignments is often self-initiated.) QualificationsExperience with development in a regulated industry such as medical device, defense, or automotive.Experience in Systems Engineering as related to stakeholder needs definition, creation of use case workflows, requirements definition and decomposition, functional architecture, and system design.Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports.Experience working on multiple projects in a deadline driven environment.Experience with RF communications systems is desirable.Ability to generate buy-in from stakeholders to solutions for both technical and non-technical issues.Ability and willingness to make sound decisions potentially with high impact in a timely manner.Ability to provide creativity while solving complex problems without known solutions. Outstanding communication and presentation skills (written and verbal) to all levels of an organization.Experience interfacing with Software Development, Mechanical, Electrical, Operations, Quality and Regulatory.Usability engineering (human factors) experience with strongly desired.Risk management experience strongly desired.Cybersecurity in medical devices experience strongly desired.Project management skills including planning and estimation of tasks, milestones, resources, and budget desired.Willing to travel up to 10% as needed.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, disability, age or other characteristics protected by laws.PI240040235