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.
The 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
It would be a plus if you also possess previous experience in:
- 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. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at .
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 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.
#LI-AE1
