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