Manufacturing Engineer 1

Cook Medical • Ellettsville, IN • 1d ago

Overview

The Manufacturing Engineer 1 is responsible for providing technical support for the day-today production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices.

Responsibilities

Provides process support for extrusion department

Hands-on position with visibility on the manufacturing floor

Requires a high level of interaction with the production, product development, and quality teams

Supports product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives

Supports production departments' manufacturing issues with technical support as the process expert. Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence

Supports and drives continuous improvement activities in the manufacturing department to improve operational performance. Leads technical aspect of process validation projects

Assist product development teams with design for manufacturability requirements on new products. Supports new capital equipment and tooling purchases with appropriate documentation and evaluation

Manages multiple technically oriented projects through coordinating internal and external resources

Collaborates on product complaint resolution

Qualifications

High School Diploma with applicable experience is required; Bachelor's degree in Engineering/Plastics Engineering preferred

3+ years of extrusion process development experience

5+ years of work related to polymer processing preferred

Process validation (IQ, OQ, PQ) preferred- Equipment qualification (IQ, OQ, PQ) preferred

Fundamental understanding engineering principles- Extrusion process development / Extrusion Tooling Design

Mechanical aptitude preferred

Understanding of ISO 13485:2016 preferred

CFR, FDA, OSHA, environmental regulations preferred

Proficiency at using Microsoft Office applications- Troubleshooting and problem-solving skills

Equipment / process troubleshooting preferred- Experience with blue print reading preferred- Design of Experiments / Six Sigma preferred

Physical Requirements:

May exert up to 20 pounds of force frequently, and/or a negligible amount of force constantly to move objects

Requisition ID2025-17242

Posting Date10 hours ago(9/5/2025 12:07 PM)

Job Location(s)Ellettsville IN United States

Job LocationsUS-IN-Ellettsville

TravelNone

Position TypeFull Time

CompanyCook Inc - Ellettsville

CategoryEngineering

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