Cook Group

Software Engineer

• Complete a 16-week rotation with assignments in Post-Market and Sustaining Engineering
• Work on projects involving process improvement, test method validation, production, continuous improvement, process technology, manufacturing transfer, supplier engineering, sustaining engineering, engineering test lab, sustaining materials, quality engineering, quality data analytics, and research and development
• Utilize engineering knowledge to produce project deliverables and documents
• Adhere to the Quality Management System and applicable FDA 21 CFR 820, ISO 13485, and other regulatory requirements
• Maintain required training and pursue continuous development and growth
• Work and interact effectively and professionally with people at various levels of the global organization
• Maintain company quality and quantity standards
• Work in collaborative and independent environments with minimal supervision

Sustaining Engineering Co-op

Data Engineer

• Define and document data and data pipelines for a variety of solutions as part of a project team
• Maintain technical responsibility for data and data pipelines
• Ensure compliance with data standards and architectural standards
• Ensure documented requirements are achieved
• Develop and maintain current-state documentation and deliverables for data solutions
• Maintain existing and new data solutions to meet user needs
• Assist operational teams to ensure continuity of service
• Identify and implement continuous improvement opportunities with the Data Engineering community of practice
• Interact regularly with senior management
• Handle complex issues and work with a high degree of latitude

Senior Data Engineer

• Complete a 16-week rotation in Research and Development Engineering
• Produce project deliverables and documents using engineering knowledge
• Follow the Quality Management System and applicable FDA, ISO, and other regulatory requirements
• Maintain required training and pursue continuous development and growth
• Work professionally with people at various levels of the global organization
• Follow workplace safety requirements
• Maintain regular and punctual attendance
• Meet company quality and quantity standards
• Work collaboratively and independently with minimal supervision on meaningful medical device manufacturing projects

R&D Engineering Co-op

• Complete project deliverables and documentation using engineering knowledge
• Work within the Quality Management System and applicable medical-device regulatory requirements
• Maintain position training requirements and pursue continuous development
• Collaborate professionally with colleagues across various levels of the global organization
• Follow workplace safety requirements
• Maintain regular attendance and company quality and quantity standards
• Work effectively in collaborative and independent settings with minimal supervision
• Complete a 12-week rotation across Research and Development Engineering teams
• Gain real-world experience through meaningful projects in the medical device manufacturing industry
• Deliver a capstone presentation

Engineer

• Lead and/or assist in post-market activities for current products
• Maintain medical device designs to ensure continued compliance with current state-of-the-art, including design changes, testing and risk management activities
• Prepare documentation to support submissions and responses to regulatory authorities
• Lead or support Corrective and Preventive Actions (CAPAs)
• Support engineering-driven projects or programs, including working with external contractors on post-market projects where applicable
• Lead or support evaluation of design-related supplier changes
• Interact effectively and professionally throughout various levels of the global organization
• Report to the Team Leader – Post Market Engineering

Engineer 2, Post Market

• Complete, collaborate on, and assist with assigned project/program activities
• Manage and drive assigned project tasks to complete project milestones on time
• Collaborate with cross-functional groups to achieve project and company goals
• Provide updates during project meetings and document minutes and actions
• Contribute to achieving project milestones and business metrics
• Interact with subject matter experts, physicians, and product managers to develop innovative medical devices that improve patient care
• Interpret data and organize, execute, and coordinate activities within portions of projects/programs
• Contribute to creating and maintaining design history files
• Assist with developing and implementing new processes and solutions
• Utilize engineering knowledge to support the department
• Provide input on company intellectual property to drive innovation and IP generation
• Participate in creative problem-solving to support product/process excellence
• Learn applicable organizational business processes and systems
• Comply with Quality, Regulatory, and company policies and systems
• Attend trade shows to source raw materials or attend company exhibitions

Research and Development Engineer

Compliance

• Fulfill premarket and post-market regulatory requirements for medical devices manufactured by Cook Group companies
• Coordinate with cross-functional teams to develop strategies for new medical devices and support existing devices
• Maintain knowledge of medical-device regulations and assess their impact on projects
• Learn new technical subjects and communicate technical and scientific information to project teams and regulatory authorities
• Coordinate with the Director of Regulatory Science to understand goals and priorities, develop project plans, and facilitate project progress
• Assess new technologies for regulatory pathways
• Collaborate with Business Units, Engineering, Clinical, and Marketing to develop and implement scientifically sound regulatory strategies
• Provide scientific review and regulatory guidance throughout projects, including non-clinical and clinical strategy development
• Review non-clinical and clinical data for accuracy, completeness, and submission suitability
• Write or coordinate clear regulatory documents and submissions to global regulatory authorities
• Provide technical, scientific, and regulatory leadership for new-device approvals and maintenance of marketed-device approvals
• Review change requests for supporting-data adequacy and reporting requirements
• Travel as necessary to support projects

Regulatory Scientist, Vascular

Customer Support

• Serve as subject matter expert on the capital equipment portfolio and service requirements
• Respond to sales team and customer questions regarding service packages, pricing, quoting, and manufacturer service recommendations
• Expedite service quotes and purchase-order acquisition for repairs identified during preventative maintenance
• Assist field-based technicians with service scheduling efficiency by identifying additional service calls in nearby geographical locations
• Manage evaluation and loaner pool inventories and order replacement parts for customers as needed
• Maintain strong product and ordering-systems knowledge
• Participate in and coordinate regional projects as required
• Communicate professionally with customers
• Process capital equipment product and service complaints
• Assign customer capital equipment service requests to service technicians
• Maintain accurate records of capital equipment service activities and ensure company procedures are met
• Ensure timely submission of service reports by service technicians
• Receive shipments of supplies and verify associated documentation
• Perform sundry tasks as directed by the manager

Customer Support Specialist 2

Product Marketing

• Collaborate with senior specialty leadership to align priorities, projects, and plans within the specialty
• Influence specialty business strategy and direction
• Align mid-term marketing strategy and annual marketing plans with business goals and brand strategy
• Develop global go-to-market strategy with product management, sales, and global functions
• Develop value propositions, claims, and messaging aligned with brand guidelines
• Ensure successful execution of global and regional product launches
• Use customer personas and buyer journeys to develop marketing strategy and plans
• Review and approve campaign tactics and marketing materials for advertising and promotions compliance
• Engage customers and subject matter experts to understand markets and customer needs
• Establish objectives for campaigns and channels, including customer meetings and events
• Provide measurable input to marketing and specialty processes, systems, and operational plans
• Independently investigate root causes of unique and difficult issues
• Manage large, complex marketing initiatives involving cross-functional teams
• Foster and maintain a respectful and supportive workplace culture

Global Product Marketing Manager – Aortic

• Apply engineering principles to solve complex technical challenges
• Ensure products meet clinical needs, safety requirements, and quality standards
• Lead small projects/programs and own portions of medium to large projects/programs
• Collaborate across functional departments and provide technical leadership
• Create procedures or white paper guidance for functional groups
• Lead technical development and key design decisions
• Conduct retrospective project reviews and implement strategic goals
• Conduct research and contribute to best practices
• Deploy knowledge and training and ensure correct implementation of new concepts and approaches
• Work with subject matter experts, physicians, and product managers to develop innovative medical devices
• Drive project tasks, milestones, and business metrics with project managers
• Interpret data and coordinate project activities
• Develop and maintain design history files
• Develop and implement new processes and solutions
• Provide technical input on intellectual property to drive innovation
• Use creative problem-solving techniques to develop medical devices and technologies
• Build and manage cross-functional relationships
• Apply company business processes and systems
• Ensure compliance with Quality, Regulatory, and company policies and systems
• Represent Cook in industry standards working groups and conferences
• Mentor other personnel and foster collaborative knowledge sharing

Senior Research and Development Engineer

General

• Work with a mentor to assess clinical, technology, and business needs and provide recommendations for new technology investments
• Collect, organize, and present research
• Contribute to team projects
• Follow procedures pertinent to assigned tasks
• Ensure accurate and complete documentation
• Support other team members when requested and reasonable
• Learn about previous research, project objectives, and deliverables
• Work with mentors and team members to define tasks
• Coordinate resources to meet project needs and deadlines

Research & Development Co-op – Bench Testing, New Ventures, Vascular, MedSurg

QA Engineer

• Provide Quality Engineering support to monitoring, approval and appraisal of suppliers from a quality perspective
• Provide support and guidance to departments liaising with suppliers from operations, engineering and quality control perspectives
• Support process and supplier validation, change requests, non-conforming product issues, CAPA, risk assessment and Quality System Documentation
• Perform supplier quality audits and manage the supplier corrective action process
• Maintain and update the supplier audit schedule
• Develop mechanisms to monitor and identify supplier non-conformance trends based on risk
• Track supplier quality KPIs and participate in supplier performance reviews
• Complete and approve supplier evaluations and monitoring
• Manage and drive continuous improvement activities focused on supplier quality
• Review and support Supplier Change Notifications
• Review and approve raw materials, first part approval and supplier process validations
• Maintain supplier quality documentation with purchasing
• Provide Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues
• Support the Cook Medical CAPA and Non-Conforming Product Process
• Support Internal Audit, Vendor Audit and Regulatory Audit Programmes
• Complete risk assessments of suppliers, non-conforming materials and CAPAs
• Provide quality measurements and ensure quality issues are prioritised and acted upon promptly
• Act as designee to the Senior Quality Engineer/Quality Engineering Team Lead
• Ensure Cook’s Code of Conduct is considered in business matters

Sustaining Engineering Co-op

Senior Data Engineer

R&D Engineering Co-op

R&D Engineering Co-op

Engineer 2, Post Market

Research and Development Engineer

Regulatory Scientist, Vascular

Customer Support Specialist 2

Global Product Marketing Manager – Aortic

Senior Research and Development Engineer

Research & Development Co-op – Bench Testing, New Ventures, Vascular, MedSurg

Quality Engineer 2, Supplier