Sr. Manufacturing Engineer - Value Engineering

Cook Group•Bloomington, IN

124d

About The Position

The Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, supporting Operations to ensure quality products are produced in a timely manner. The role works with Operations, Quality Assurance, and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality. The engineer also supports operational departments with materials, equipment, and process upgrades; contributes to projects from planning through validation; and prepares accurate documentation consistent with applicable regulations and Cook’s Quality Management System. The role requires effective collaboration across organizational levels, adherence to safety and quality requirements, punctual attendance, and the ability to work independently or collaboratively with minimal supervision in a fast-paced environment.

Requirements

Bachelor’s degree or higher in an engineering discipline; Biomedical, Mechanical, or Chemical Engineering is specified.
At least 5 years of industry experience.
Manufacturing Engineering or Design/Post Market Engineering background.
Medical device experience.
Ability to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

Nice To Haves

Master’s degree preferred.
Experience with value-stream mapping.
Experience with Lean and/or Six Sigma, with corresponding certification.
Experience with Kaizen/Continuous Improvement, with corresponding certification.
Experience leading major manufacturing cost-savings efforts through process and/or design changes.

Responsibilities

Work with Operations Managers and outside vendors to create methods and machines that support manufacturing 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.
Train relevant personnel on new processes.
Document cost savings.
Write and execute validation protocols.
Ensure projects follow design controls established by Quality System Procedures (QSPs).
Work with Quality Assurance and Product Development to verify and validate critical processes or products.
Work with management to establish project timelines and business cases.
Serve as a resource for operational departments on materials, equipment, and process upgrades.
Maintain required training and pursue opportunities for continuous development and growth.
Prepare and maintain accurate documentation consistent with applicable regulations and Cook’s Quality Management System.
Interact effectively and professionally with people throughout the global organization.
Adhere strictly to safety requirements and maintain regular, punctual attendance.
Maintain company quality and quantity standards.
Communicate effectively and work collaboratively or independently with minimal supervision.
Remain calm and receptive in fast-paced situations.