Manufacturing Engineer 2 (Extrusion/Injection Molding Exp)

Cook Medical; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Cook Polymer Technology in Bloomington, IN, is seeking a Manufacturing Engineer 2 with extrusion and injection molding experience to optimize production and drive quality improvements. The role collaborates with Operations, QA and Regulatory Affairs to enhance throughput and reduce costs while maintaining regulatory compliance.

The ideal candidate has a technical engineering background with broad experience in manufacturing processes, equipment validation, and cross-functional teamwork to

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in Quality Engineering, Manufacturing Engineering or Development Engineering (5–7 years).
• Knowledge of medical device regulations and quality tools.
• Experience in project management and handling multiple activities.

Responsibilities

• Develop, maintain, and improve manufacturing and inspection processes.
• Perform equipment and process validations and testing to internal procedures and external standards.
• Define equipment maintenance requirements and design/improve equipment.
• Train manufacturing and QC operators and coordinate with procurement.
• Support NCRs/CRs/CAPAs and supplier change evaluations related to processes.
• Collaborate with R&D, Manufacturing, Operations, Regulatory Affairs and other departments.
• Ensure QMS compliance and drive continuous improvement to minimize downtime and lead time.

Skills

Mechanical engineering

Quality engineering

Cross-functional collaboration

Process validation

Education

Bachelor's degree in Engineering

Job description

Manufacturing Engineer 2 (Extrusion/Injection Molding Exp)

Bloomington IN United States

US-IN-Bloomington

Cook Polymer Technology

Overview

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.

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.
• 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.

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
• Knowledge of quality tools and principles
• Experience in project management and managing multiple activities preferred

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.