Manufacturing Engineer 1

Cook Medical Inc.; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Cook Inc - Bloomington is seeking a Manufacturing Engineer 1 to plan, direct, and optimize manufacturing processes for medical device products. The role collaborates with Operations, Quality Assurance, and Regulatory Affairs to drive throughput, quality, and cost improvements.

Responsibilities include developing processes with Product Development, training staff, documenting cost savings, and conducting validations under design controls.

Qualifications

• Bachelor's degree in Engineering required.
• Strong problem solving and communication skills.
• Ability to work cross-functionally with Operations, QA, and Regulatory Affairs.

Responsibilities

• Plan, direct, and coordinate manufacturing processes for medical device products.
• Collaborate with Operations, Product Development, and QA to improve processes and reduce costs.
• Train personnel on new processes and document procedures.
• Write and execute validation protocols and ensure design controls compliance.
• Support calibration activities and verify critical processes.

Skills

Analytical thinking

Attention to detail

Communication

Collaboration

Education

Bachelors in Engineering

Job description

Manufacturing Engineer 1

Job Details

• Job Location(s) Bloomington IN United States
• Job Locations US-IN-Bloomington
• Position Type Full Time
• Company Cook Inc - Bloomington
• Category Engineering

Overview

The Manufacturing Engineer 1 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 Production 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 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).
• Provide support to the calibration department in writing/performing calibration procedures.
• Work with Quality Assurance and Product Development to verify/validate critical processes or products.
• Work with management to establish project timeliness,and project justification.
• 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 Management System 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

Bachelor’s Degree in Engineering
- A degree in Mechanical, Electrical, Production, or Manufacturing Engineering preferred

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.

Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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.