Senior V&V Engineer - Medical Devices

United Pharma; Colorado; On-site; USD 95,000 - 135,000; Full time

Job summary

United Pharma in Layfayette, Colorado is seeking an experienced Test Validation Engineer to lead system verification and validation for interventional medical devices. The role focuses on developing robust test methods, validation plans, and regulatory documentation to ensure design inputs are verified through the V-model.

You will partner with Systems Development, Quality, and Regulatory teams to drive evidence-based testing, create protocols with justification, and deliver regulatory

Qualifications

• Bachelor’s degree in engineering or a scientific discipline with 6+ years in technical testing or engineering.
• Experience leading system-level verification planning, execution, and documentation.
• Experience supporting system-level validation planning, execution, and documentation.

Responsibilities

• Lead verification and validation for interventional medical devices.
• Develop verification plans, test methods, and validation reports.
• Create acceptance criteria and sample size justifications for protocols.
• Collaborate with design quality, systems, mechanical/electrical engineering, and labs to drive V-model testing.
• Document verification evidence for regulatory submissions and risk management.

Skills

Test Method Development

System Verification Planning

Documentation & Regulatory

Education

Bachelor's degree in engineering or scientific discipline

Job description

United Pharma in Layfayette, Colorado is seeking an experienced Test Validation Engineer to lead system verification and validation for interventional medical devices. The role focuses on developing robust test methods, validation plans, and regulatory documentation to ensure design inputs are verified through the V-model.

You will partner with Systems Development, Quality, and Regulatory teams to drive evidence-based testing, create protocols with justification, and deliver regulatory