Verification Engineer II

Danaher•Chaska, MN

3d•Onsite

About The Position

The Verification Engineer II is responsible for leading and executing verification and validation activities on the immunoassay product line. This includes hands-on work with diagnostic instruments, authoring and executing verification and validation protocols, investigating anomalies, and partnering with the broader R&D team to ensure compliant, on-time delivery of verification and validation deliverables for both new development and existing products. 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.

Requirements

Bachelor’s degree in Science, Engineering, or related field with 2+ years of experience (or Master’s degree with 0-2 years of experience) in verification, validation, test, or laboratory-based engineering in a regulated or quality-driven environment
Demonstrated ability to independently execute and troubleshoot test protocols in a laboratory setting, including use of calibrated equipment and accurate data capture
Strong attention to detail with working knowledge of regulated documentation practices (e.g., GDP/ALCOA principles), and ability to summarize results clearly for technical and quality stakeholders

Nice To Haves

Previous experience in Medical device, IVD, biotech, or other FDA/ISO regulated environments
Experience supporting design controls, risk management, and/or requirements traceability
Successful integration of software and hardware solutions into a commercial product

Responsibilities

Develop and maintain verification and validation strategies and test plans for moderate-to-complex hardware and software features in support of new product development and continuous delivery of hardware and software designs.
Work directly on diagnostic analyzers by performing maintenance, calibration, and other readiness checks.
Support troubleshooting of systems to ensure reliable test execution and root-cause investigations.
Author, review, and execute verification and validation protocols in accordance with approved procedures and documentation standards; providing clear, defensible results that are traceable to requirements.
Partner with cross-functional teams (Hardware, Systems, Software, Assay, Quality, and Manufacturing) to plan test execution, communicate status and risks, investigate nonconformances, and drive timely closure of issues and deliverables; may provide guidance to less experienced engineers/technicians.