System Engineer

The Systems Engineer at Cook Medical will support Cook's enterprise-wide product lifecycle management (PLM) software and related systems according to system lifecycle state, including design, implementation and sustaining activities. The Systems Engineer works with process owners to optimize R&D processes utilizing PLM software, provide input to PLM design, and to support R&D users in use of PLM.

For PLM systems in the design lifecycle state:
• Work with stakeholders to define business needs and user requirements
• Understand PLM design, including how PLM influences other systems
• Participate in and/or lead the design of PLM system functionality
• Develop procedures for management and utilization of the PLM system
• Work with IT to coordinate PLM system validation
• Develop training materials to support new PLM system functionality
For PLM systems in the implementation lifecycle state:
• Define plans and responsibilities for implementing new PLM systems
• Coordinate with site teams to implement new PLM functionality, including data migration, policy/procedural changes, and training
• Manage projects to procure and implement off-the shelf software that improves engineering processes and workflows
• Ensure that lessons learned are captured following implementation

For PLM systems in the sustaining lifecycle state:
• Monitor PLM user requests and performance data to identify PLM system improvements; provide feedback to PLM teams
• Identify, prioritize, and manage PLM system improvement projects
• Assess PLM system upgrades from suppliers and recommend action
• Draft/update global PLM procedures to support functionality; maintain procedures and training materials to reflect system changes
• Assess compliance with established PLM policies and procedures
• Identify opportunities to improve overall efficiency, consistency and alignment across Cook
• 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

Cognition Cockpit is the software tool within the PLM pod that Cook has selected to support requirements management, risk management, and process validation.  The new Systems Engineer will work together with another PLM engineer to continue design and implementation of Cognition Cockpit, specifically:

• Support implementation of Cockpit for the Cook, Inc. Design History File remediation team
• Assess strategies to align the new Global Cook Medical Design Control, Risk Management, and Process Development processes and the Cook, Inc. implementation of Cockpit
• Lead Cockpit project or sub-project
• Train users
• Identify and develop additional opportunities to improve the quality and/or efficiency of product development and sustaining activities, risk management, and/or process validation through the deployment of additional Cockpit functionality
• Transform user needs into Cockpit templates
• Collect input from business stakeholders, including R&D, Postmarket Engineering, CAPA Engineering, Regulatory Affairs, Quality Engineering, etc.
• Coordinate validation of Cockpit core functionality and templates
• Coordinate development of Cockpit-specific procedures and instructions
• Support site Cockpit leads/super users

• Bachelor's degree required and/or equivalent relevant work experience in Engineering, preferably in Mechanical, Chemical, or Biomedical
• Experience in R&D and/or new product development
• Experience across broad range of R&D tools, data, and processes
• Preferred qualifications: Experience as a project manager and/or work related to design, implementation, or sustaining electronic PLM 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.
• Experience working in a global environment / global teams across many cultures and regions, managing and executing complex projects / programs in an engineering environment

Physical Requirements:

• Approximately 90% of the time is spent in a normal office environment requiring sitting and moving around the building, approximately 10% of time is spent in domestic/international travel to various locations to support project activities; Engineers supporting implementation could travel up to 50% during some projects