Senior Verification and Validation Engineer

Danaher•Chaska, MN

1d•$100,000 - $130,000•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? 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. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, 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, and are used 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, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

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.