Manufacturing Engineer 2 (Extrusion/Injection Molding Exp)

Cook Group•Bloomington, IN

153d

About The Position

The Manufacturing Engineer 2 plans, directs, and coordinates manufacturing processes for medical device products, supporting Operations to ensure quality products are produced on time. The role works with Operations, Quality Assurance, Regulatory Affairs, and other cross-functional teams to improve product designs and manufacturing processes, increase throughput, reduce costs and downtime, improve quality, and support production objectives in compliance with the Quality Management System and applicable standards and regulations. The position develops and maintains manufacturing, inspection, cleanliness, and environmental-control processes; performs process and equipment validations; defines equipment maintenance requirements; and designs, improves, implements, diagnoses, and repairs manufacturing equipment and tooling. It also supports operator training, supplier issue resolution, calibration, process failure mode and effects analyses, and continuous improvement. The engineer manages and supports manufacturing-related non-conformance records and investigations, change requests, corrective and preventive actions, and supplier change evaluations. The role collaborates with Product Development, R&D, Operations, Quality, Regulatory Affairs, vendors, and other Cook companies to develop processes for new products, resolve production issues, and improve product capacity and profitability.

Requirements

Bachelor's degree in Engineering or a 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.

Nice To Haves

Experience in project management and managing multiple activities.

Responsibilities

Develop, maintain, and improve manufacturing and inspection processes and procedures.
Perform equipment and process validations and testing in accordance with internal procedures and 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, and supplier issue resolution.
Assist with equipment and instrument calibrations, perform process failure mode and effects analyses, and repair equipment and tooling.
Work with Operations Managers and outside vendors to create methods and machines that support product capacity.
Work with Product Development Engineers to develop processes for new products.
Work with Operations, Accounting, and Global Product Managers to increase profit margins for current products that do not meet company requirements.
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 manufacturing-related Non-Conformance Records and Investigations (NCRs, NCIs), Change Requests (CRs), Corrective and Preventative Actions (CAPAs), and Supplier Change Evaluations (SCEs).
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 and organizing validation tests.
Collaborate with internal stakeholders to efficiently resolve production-line non-conformances.
Collaborate with 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 support collaboration and integration of new technologies.