Manufacturing Engineer 2 (Extrusion/Injection Molding Exp)

Cook Group; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Cook Group in Bloomington, IN is seeking a Manufacturing Engineer 2 to plan, direct, and optimize medical device manufacturing processes. You will work with Operations, Quality Assurance, and Regulatory Affairs to improve throughput, reduce costs, and enhance product quality.

The role requires a Bachelor's degree in Engineering and 5–7 years in quality or manufacturing engineering, with knowledge of medical device regulations and project management experience.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5–7 years in Quality Engineering, Manufacturing Engineering or Development Engineering.
• Knowledge of medical device regulations, pertinent standards and guidelines.
• Project management experience and ability to manage multiple activities (preferred).

Responsibilities

• Develop, maintain, and improve manufacturing and inspection processes/procedures.
• Perform equipment and process validations and testing to internal procedures and external standards.
• Define equipment maintenance requirements and improve tooling/equipment.
• Collaborate with Operations, QA, Regulatory Affairs, and suppliers to resolve issues.
• Support NCRs, CAPAs, and change evaluations related to manufacturing processes or products.
• Drive continuous improvement to reduce downtime and improve lead times.

Skills

Quality tools

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Job description

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 andguidances
• Knowledge of quality tools and principles
• Experience in project management and managing multiple activitiespreferred