Sound Engineer Salary in Redwood City, CA

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.

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.

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