Senior Verification and Validation Engineer

Overview Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, works to save lives and is united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough to rapid and reliable sample analysis, we enable clinicians to deliver the best possible care with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Senior Verification & Validation Engineer is responsible for owning and driving verification and validation strategy and execution for the immunoassay product line, including risk-based planning, complex troubleshooting, and cross-functional technical leadership. This role leads the development of verification/validation approaches, authors, executes and approves protocols and reports, ensures traceability to design inputs and risk, and drives investigation and resolution of anomalies to enable compliant, on-time delivery of verification and validation deliverables. This position will be an on-site role in Chaska, Minnesota and reports to the Verification and Validation Manager as part of the Global Systems V&V Organization. In This Role, You Will Have The Opportunity To Lead the verification and validation strategies for moderate-to-high complexity hardware/software features, including risk-based test planning, coverage rationale, and alignment to design inputs, intended use, and applicable standards. Serve as the primary technical driver for lab execution on diagnostic analyzers (maintenance, calibration, readiness, and complex troubleshooting), ensuring reliable test execution and leading root-cause investigations with clear problem statements, data-driven conclusions, and corrective actions. Author, review, approve, and execute verification/validation protocols and reports in accordance with approved procedures and documentation standards; ensure end-to-end requirements traceability and defensible statistical/technical rationale as appropriate. Influence and align cross-functional stakeholders (Hardware, Systems, Software, Assay, Quality, and Manufacturing) on V&V scope, schedules, and risk; lead issue triage and prioritization; communicate technical status and escalation paths. Mentor less experienced engineers/technicians and contribute to continuous improvement of V&V processes, templates, and laboratory best practices. Essential Requirements Of The Job Include Bachelor’s degree in Science, Engineering, or related field with 5+ years of experience (or Master’s degree with 3+ years of experience) in verification/validation, systems/test engineering, or laboratory-based engineering, preferably in a regulated (FDA/ISO) environment. Proven ability to independently lead complex laboratory investigations and troubleshoot hardware/software/system interactions; able to develop test approaches, define acceptance criteria, and drive execution through ambiguity. Strong working knowledge of design controls, requirements traceability, and regulated documentation practices (e.g., GDP/ALCOA); demonstrated ability to communicate technical results, risks, and recommendations to engineering and quality leadership. Travel, Motor Vehicle Record & Physical/Environment Requirements Up to 10% global travel required. Preferred Experience Medical device/IVD product development experience, including design controls and risk management (e.g., ISO 13485, ISO 14971), and successful support of verification/validation for submissions and/or design changes. Experience leading integration verification for complex electro-mechanical systems with embedded software, including test automation, data analysis/statistics, and/or intermittent failure reproduction. Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. The annual salary range for this role is $100,000-$130,000. 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 range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. For more information, visit 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. For candidates outside New York City, information about conditions of any job offer can be found 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, or to receive other benefits and privileges of employment, please contact: View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr Beckman Coulter Diagnostics