Manufacturing Engineer 2

The Manufacturing Engineer 2 plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

• 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.
• Must maintain a positive and professional representation of the company.

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.

• 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
• Knowledge of quality tools and principles

• Experience in project management and managing multiple activities preferred