Senior V&V Engineer, Immunoassay Systems

Beckman Coulter Diagnostics; Chaska (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

Beckman Coulter Diagnostics in Chaska, MN, seeks a Senior Verification & Validation Engineer to own V&V strategy and execution for the immunoassay product line. You will lead risk-based planning, complex troubleshooting, and cross-functional technical leadership to enable compliant, on-time delivery of verification and validation deliverables.

The role requires a Bachelors or Masters in science/engineering with 5+ years (or 3+ years with a Masters) in verification/validation, systems/test

Qualifications

• Bachelors or Masters in science/engineering with relevant experience.
• Experience leading lab investigations and troubleshooting.
• Knowledge of design controls and regulatory documentation.
• Ability to communicate with engineering and quality leadership.

Responsibilities

• Define and drive verification/validation strategy and execution for the immunoassay product line, including risk-based planning.
• Author, review, approve, and execute verification/validation protocols and reports with traceability to design inputs and risk.
• Lead cross-functional collaboration with Hardware, Systems, Software, Assay, Quality and Manufacturing on V&V scope and schedules.
• Mentor junior engineers/technicians and drive continuous improvement of V&V processes and lab practices.

Skills

V&V leadership

Lab investigations

Design controls

Requirements traceability

Cross-functional leadership

Education

Bachelor's degree in Science or Engineering

Master's degree in Science/Engineering

Job description

Beckman Coulter Diagnostics in Chaska, MN, seeks a Senior Verification & Validation Engineer to own V&V strategy and execution for the immunoassay product line. You will lead risk-based planning, complex troubleshooting, and cross-functional technical leadership to enable compliant, on-time delivery of verification and validation deliverables.

The role requires a Bachelors or Masters in science/engineering with 5+ years (or 3+ years with a Masters) in verification/validation, systems/test