Validation Engineer, AIX

Validation Engineering for New Product Development & Sustaining Engineering with a focus on software systems. Under minimal supervision, the Validation Engineer will work closely with QE, R&D, Marketing, Product Development teams, Supply Chain, and Regulatory to bring products to market while ensuring compliance to applicable standards and regulations.

Essential Duties and Responsibilities

• Manage verification and validation activities for new product development & sustaining engineering projects.

• Provides Verification and Validation Engineering expertise for Design Controls to ensure efficient, effective, and compliant new product launches including requirements evaluation, end-to-end traceability and the establishment of V&V Plans.

• Manual and automated system test method development and qualification.

• Represent Quality Engineering when collaborating with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles of Software Validation), including but not limited to Requirements Specifications, Validation/Test Plan, Testing, Integration Test Scripts, Operational/System Test Scripts, Validation Summary Reports.

• Assist with Risk Management efforts in accordance with ISO 14971.

• Maintain regular and consistent attendance at the normal worksite.

• Other duties as assigned.