Manufacturing Engineer 2

Responsibilities

• Develop, maintain, improve manufacturing and inspection processes/procedures.
• Perform equipment and process validations and testing to internal procedures and/or external standards.
• Develop cleanliness and environmental control processes and procedures.
• Define equipment maintenance requirements.
• Design and improve manufacturing and inspection equipment.
• Assist with training manufacturing and QC operators, procurement, resolving issues with suppliers.
• Assist with equipment instrument calibrations, performing process failure mode effects analyses and repairing equipment and tooling.
• Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products.
• Work with Product Development Engineers to develop processes for new products.
• Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements.
• Perform all tasks in compliance with the Quality Management System (QMS) to a competent and professional standard.
• Provide engineering support to optimize manufacturing processes, minimize downtime, and improve product lead time.
• Diagnose and repair process equipment and associated facilities to ensure reliable operation.
• Evaluate, manage, and support Non-Conformance Records and Investigations (NCRs, NCIs), Change Requests (CRs), Corrective and Preventative Actions (CAPAs), and Supplier Change Evaluations (SCEs) related to manufacturing processes, equipment, or products.
• Implement new equipment and processes to drive continuous improvement and efficiency in the manufacturing environment.
• Develop and implement methods to monitor and assess manufacturing processes for quality and compliance.
• Perform process validation activities, including writing protocols and reports, as well as organizing validation tests.
• Work collaboratively with internal stakeholders to resolve non-conformances in the production line efficiently.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Operations, Regulatory Affairs, and other departments, to drive technical decisions and solutions.
• Support production and quality teams in maintaining and improving quality and production objectives while adhering to established standards and regulatory requirements.
• Liaise with external vendors and other Cook companies to ensure smooth collaboration and integration of new technologies.

  Qualifications

  • Bachelor's degree in Engineering or related technical field; at least 5-7 years of experience in Quality Engineering, Manufacturing Engineering or Development Engineering.
  • Knowledge of medical device regulations, pertinent standards and guidances.
  • Experience in quality tools and principles.
  • Experience in project management and managing multiple activities preferred.