Design Assurance Engineer

Design Assurance provides input, support and guidance to new product / process development (NPD) teams and ensures that documentation is compliant with established Cook Medical quality system requirements.

• Coach and advise NPD teams on the application of Cook Medical global Design Controls, Process Development and Risk Management policies, procedures, and systems
• Serve as a direct team member on assigned new product development projects, providing input into the project
• Review project-related deliverables for compliance with Cook Medical policies and procedures
• Contribute towards and participate in design reviews
• Support development and deployment of Cook Medical global Design Controls, Process Development and Risk Management policies & procedures
• Participate as global trainer/subject matter expert in specific procedures and systems, as requested

• Develop and maintain a broad understanding of Cook Medical Design Controls, Process Development and Risk Management policies, procedures, and systems
• Maintain thorough knowledge of applicable regulations, standards, and guidance documents
• Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards, including Cook policies
• Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met

• Bachelor's degree in Engineering, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines
• Minimum 3 years experience in R&D and/or new product development, process development or quality assurance / quality engineering
• Experience across broad range of Design Controls, Process Development and Risk Management procedures and systems

• Effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

Physical Requirements:

• Approximately 95% of the time is spent in a normal office environment requiring sitting and moving around the building. Approximately 5% of time is spent in domestic/international travel to various locations to support project activities

• Collaborate with peers and Managers regularly through on-line communication methods at times during and outside of normal working hours being flexible in accommodating these demands
• Must be able to perform the essential functions of the job, with or without reasonable accommodations