Job Description

Overview The Senior Quality Engineer is responsible for driving manufacturing and product lifecycle quality by implementing a risk-based approach to ensure compliance with corporate policies, 21 CFR 820, ISO 13485, and other regulatory standards, while championing continuous improvement. You will play a pivotal role in New Product Introduction (NPI) and Change Control processes, ensuring accurate and complete quality deliverables during design transfer to manufacturing. This includes reviewing change orders and deviations to confirm clear, well-documented rationales and comprehensive impact assessments for significant changes. By developing robust qualification strategies, you will proactively mitigate risks associated with design and process modifications, enhancing product reliability and supporting innovative product development. Location: Sunnyvale, CA (on-site). Responsibilities Lead quality engineering efforts for PCR-based assay development, including analytical method validation, reagent qualification, and system-level performance verification. Serve as the primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment, providing strategic input on design control, risk management, and quality compliance. Drive risk assessment activities including safety, design and process FMEA, with a focus on assay sensitivity, reagent compatibility, specificity, and robustness. Create project-specific documents, such as validation master plans, risk management plans, and qualification protocols, to meet compliance requirements. Address nonconformities and deviations through risk assessment, root cause identification, failure mode analysis, and proposing disposition. Qualifications BS degree in chemistry, molecular biology, biomedical engineering, or related field with 5+ years of quality engineering experience, master’s degree with 3+ years experience, OR Doctoral degree with 1+ year(s) experience. Proven experience in assay development, including method validation, troubleshooting, performance characterization and continuous process improvement for biological assays and processes. Experience in NPI Quality for complex systems, including design verification and validation, part qualification and test method validation. Experience in the application of process control plans, statistical process control, and quality system regulations (e.g., 21 CFR 820, ISO 13485). Demonstrated ability to lead cross-functional teams and guide product development from concept to commercialization. Preferred Experience in biomedical or medical device manufacturing Certified Quality Engineer and/or Lead Auditor certification Salary, Benefits, and About The annual salary range for this role is $111,100 – 135,500. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay. We offer comprehensive benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan. Check out our benefits at Danaher Benefits Info. Equal Opportunity and Accommodations Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com. #J-18808-Ljbffr Danaher Life Sciences

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