Reviews product design inputs with teams, and conducts product design verification/validation testing for compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements, and related specifications.
Plans and implements design verification/validation testing through the use of feasibility test requests, or verification/validation protocols and reports as necessary for product development.
Supports product development teams in developing test protocols/reports and test fixture designs. Acquires test articles and coordinates testing with R&D lab.
Coordinates preparation and completion of project deliverables, design documents, drawings and device master record packages as assigned.
Works closely with Regulatory Affairs to support, develop and implement Corrective and Preventative Action plans.
Works closely with Regulatory Affairs to develop paperwork and Design History Files as required to support FDA submissions.
Coordinates activities concerned with technical tasks, engineering design testing, design control tasks and sustaining engineering design changes as assigned.
Evaluates and approves design changes, specifications, and testing results.
Provides task status and progress reports to project team, and project team leaders.
Interfaces with manufacturing, purchasing, quality, test laboratory personnel, marketing and others to accomplish assigned tasks.
Supports product prototyping and development with CAD design and drawing creation as necessary.
