Lead Manufacturing Engineer - Value Engineering

americas-cookmedical; Bloomington (IN); On-site; USD 85,000 - 125,000; Full time

Job summary

Cook Medical in Bloomington, IN seeks a Manufacturing Engineer to plan, direct, and coordinate manufacturing processes for medical device products, partnering with Operations, QA, and Regulatory Affairs to improve throughput and quality.

You will develop processes for existing and new products, validate critical steps, document cost savings, and mentor staff while maintaining safety and regulatory compliance.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, or Chemical Engineering.
• Minimum 7 years of experience in industry.
• Medical device experience required.

Responsibilities

• Collaborate with Operations and vendors to improve manufacturing capacity.
• Develop processes for new products with Product Development Engineers.
• Validate critical processes and ensure design controls compliance.

Skills

Process improvement

Project management

Documentation

Quality systems

Education

Bachelor's degree in Biomedical/Mechanical/Chemical Engineering

Master’s degree preferred

Tools

Value-stream mapping

Lean Six Sigma

Kaizen/Continuous Improvement

Job description

Overview

The Manufacturing Engineer 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

• Work with Operations Managers and outside Vendors to create methods/machines to help with manufacturing 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.
• Train all relevant personnel on new processes.
• Document cost savings.
• Write and execute validation protocols.
• Assure projects follow design controls established by QSPs (Quality System Procedures).
• Work with Quality Assurance and Product Development to verify/validate critical processes or products.
• Work with management to establish project timeliness, and a project business case.
• Act as resource for operational departments for materials, equipment and process upgrades.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook’s Quality ManagementSystem where applicable.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

Requirements:

• Minimum Bachelor’s degree in an engineering discipline, preferably Master’s degree.
• Disciplines in Biomedical, Mechanical, or Chemical Engineering.
• Minimum 7 years of Experience in Industry.
• Manufacturing Engineering or Design/Post Market Engineering background.
• Medical Device experience.

Preferred Experience:

• Experience with value-stream mapping.
• Experience with Lean and/or Six Sigma and corresponding certification.
• Experience with Kaizen/Continuous Improvement and corresponding certification.
• Experience in leading major cost savings efforts in manufacturing (via process and/or design changes).

Physical Requirements:

• Works under general office environmental conditions. Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Frequently required to stand, walk, and communicate.
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.