Senior Verification and Validation Engineer

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. As a global leader in clinical diagnostics, our solutions are used in routine and complex clinical testing across hospitals, reference and research laboratories, and physician offices worldwide. Every hour, more than one million tests are run on our systems, impacting 1.2 billion patients and over three million clinicians annually.

About the role

The Senior Verification & Validation Engineer is responsible for owning and driving verification and validation strategy and execution for the immunoassay product line. This includes risk-based planning, complex troubleshooting, and cross-functional technical leadership. The 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 deliverables. This is an on-site role in Chaska, Minnesota.

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.

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.
• Up to 10% global travel required.

Preferred Qualifications

• 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.

Benefits

Beckman Coulter Diagnostics offers a broad array of comprehensive, competitive benefit programs, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees.

Pay

The annual salary range for this role is $100,000-$130,000. This role is also eligible for bonus/incentive pay.