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Overview
Responsible for providing technical support for the day-to-day production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices. This is a hands-on position with visibility on the manufacturing floor and requires a high level of interaction with the production, product development, and quality teams. The engineer is responsible for supporting product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives.
Responsibilities
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.
May be asked to perform other duties as required.
Qualifications
D: Qualifications
Minimally Required
Identify those items that are minimally required to perform the essential duties of the role.
Preferred/Specialized
These arenotrequired to perform the basic functions of the role
Education
Formal education (i.e. High School Diploma, Bachelors degree, formal certification)
Bachelors degree in related field
High School Diploma with applicable experience
Bachelors degree in Engineering
Experience
Type or number of years directly related work experience
No experience required with appropriate formal education.
3 years of work related to polymer processing
Process validation (IQ, OQ, PQ)
Equipment qualification (IQ, OQ, PQ)
Knowledge
Commonly known principles required for this field of work. For example, HVAC certifications, generally accepted accounting principles
Fundamental understanding engineering principles
Mechanical aptitude
ISO 13485:2016
CFR, FDA, OSHA, environmental regulations
Skills
Measurable learnings (i.e. can perform intermediate Excel and Word functions, advanced knowledge of research protocols)
Proficiency at using Microsoft Office applications
Troubleshooting and problem-solving skills
Equipment / process troubleshooting
Blue print reading
Design of Experiments / 6 Sigma
Requisition ID2023-13036
Posting Date7 months ago(9/11/2023 11:17 AM)
Job Location(s) Bloomington IN United States
Travel Less than 10%
Shift Type 1st shift
Position Type Full Time
Company Cook Polymer Technology
Category Engineering
Full Time
$85k-100k (estimate)
04/25/2024
05/11/2024
cookmedical.com
BLOOMINGTON, IN
3,000 - 7,500
1963
M KEM HAWKINS
$500M - $1B
Medical Technology