Senior Verification and Validation Engineer
About The Position
At Beckman Coulter Diagnostics, a Danaher operating company, we are seeking a Senior Verification & Validation Engineer to join our life sciences, diagnostics, and biotechnology team. This role is crucial for driving verification and validation strategies and execution within the immunoassay product line. You will be responsible for risk-based planning, complex troubleshooting, and providing cross-functional technical leadership. The position involves leading the development of V&V approaches, authoring, executing, and approving protocols and reports, ensuring traceability to design inputs and risks, and resolving anomalies to ensure compliant and timely delivery of V&V deliverables. This is an on-site role in Chaska, Minnesota, reporting to the Verification and Validation Manager within the Global Systems V&V Organization. Our work at Beckman Coulter Diagnostics is dedicated to improving patient health through innovative diagnostic solutions, and we foster a culture of belonging and continuous improvement.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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.
Benefits
- Paid time off
- Medical/dental/vision insurance
- 401(k)
- Bonus/incentive pay
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What This Job Offers
Job Type
Full-time
Career Level
Senior
