Sr. Manager, Systems Engineering, Point-Of-Care

The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.The RoleAt QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager, Systems Engineering, supporting our Point-of-Care instruments.This Senior Manager of Systems Engineer provides technical leadership and accountability for the development of complex, multi-disciplinary systems—spanning hardware, software, consumable and assay integration in complex diagnostic systems. The role will lead system design efforts to collaborate with engineers, scientists, and cross-functional partners to investigate, design, and resolve system- level technical challenges.This position will be onsite full-time in San Diego, CA (Summers Ridge – Sorrento Valley).The ResponsibilitiesSystems Engineering & IntegrationSystems lead in new product development programsSystems Engineering subject matter expert within systems teamOversee the architecture, integration, and verification of complex diagnostic systems, ensuring alignment with product requirements and regulatory standards.Manage integration activities between external hardware/firmware development partners and internal software engineering teamsEnsures accurate documentation of system requirements, interface specifications, and integration test plans data, and decisionsProvides solutions to complex system-level technical problemsCollaborates cross-functionally to define, decompose, verify, and validate system requirementsConduct system level risk analysis and ensure mitigation strategies are implementedEnsure compliance with relevant ISO standards (ISO 14971, IEC 62366, IEC 60601, etc.)Interfaces with manufacturing partners for effective system design transferCross-Functional LeadershipServe as the technical liaison between partners and internal teamsTechnical Lead for cross-functional project teams including but not limited to R&D, Quality, Manufacturing, Regulatory, Clinical Affairs.Facilitate effective communication and problem-solving across distributed teamsDrive technical decision-making and resolve integration challengesPresent technical updates to senior leadership and stakeholdersMentorship and Technical GuidanceMentor and provide technical guidance to junior engineers on system engineering principles and best practicesFoster a culture of continuous improvement and technical excellenceKeep abreast and share knowledge of updates to technical standardsPerform other work-related duties as assigned.The IndividualRequired:Minimum of 10+ years’ experience with bachelor’s degree in engineering or related field, master’s degree preferred; and/or equivalent combination of education and experience.Proven track record of successfully bringing medical devices or Point of Care IVD instruments Demonstrated experience leading a systems design effort from concept to commercial launch in a regulated environment.Experience in medical devices/diagnostics and regulated environmentsExperience managing external development partners and/or working with contract manufacturing partnersExperience and training in a specific discipline such as Mechanical,Electrical, Fluidics or SW engineering working knowledge in both hardware and software systemsStrong Familiarity with ISO 13485, IEC 62366, IEC 60601, ISO 14971 standardsUnderstanding of verification and validation strategies for complex systemsProven ability to lead without direct authority and influence cross-functional teamsStrong communication, analytical, and teamwork skillsAbility to travel up to 10%This position is not currently eligible for visa sponsorship. The Key Working RelationshipsInternal Partners:Engineering TeamProgram ManagersAssay Development ScientistsManufacturing TeamDesign QualityRegulatory AffairsExternal Partners:Contract design and manufacturersElectrical Safety Test ContactsVendorsHow We WorkAt QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact:Thrive Together – Collaborate intentionally, grow as a teamMake It Happen – Focus on priorities, embrace continuous improvementCommit to Service – Cultivate a service mindsetEmbrace Inclusion – Be open and authentic, welcome diverse perspectivesThe Work EnvironmentThe work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlinesPhysical Demands No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation.Salary TransparencyThe salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $165,000 to $180,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at View email address on click.appcast.io.#LI-TO1SummaryLocation: US - CA - San Diego - Summers RidgeType: Full time