Manufacturing Engineer 2
Share
Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
The Manufacturing Engineer is responsible for providing technical support for the day-today manufacturing/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
Bachelors degree in Engineering or related technical field; at least 5 years of experience in Manufacturing Engineering Production Engineering
Knowledge of medical device regulations pertinent standards andguidances
Knowledge of quality tools and principles
Experience in project management and managing multiple activitiespreferred
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
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
