Engineer 2, Sterilization
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Job Location:
Ellettsville, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Overview
The Sterilization Engineer 2 works cross-functionally to support daily sterilization operations as well as local and global process and equipment improvement projects to meet the needs of the local entity and global organization. The position will utilize multiple engineering and scientific disciplines to support complete life-cycle of projects equipment and systems.
Responsibilities
- Support in project planning documentation design construction start-up commissioning and qualification equipment and systems.
- Read and comprehend drawings and specifications to develop/modify CAD drawings for equipment facility or systems.
- Develop maintain improve sterilization process and equipment and provide associated training.
- Define and create technical specifications and validation documentation for a wide variety of projects.
- Ensure new or modified asset information is properly transferred into Maintenance and Calibration systems.
- Possess the ability to support multiple complex projects with a high level of detail and accuracy.
- Understand complex systems and be able to identify potential areas of improvement.
- Ability to work hands on and support calibration requirements with critical equipment/systems.
- Adhere to the QMS and its processes to meet FDA 21 CFRISO 13485 ISO 11135 and other applicable regulatory requirements.
- PLC interface and configuration/troubleshooting of such equipment.
- Continuously improve existing processes equipment and systems using conceptualizing rationale reasoning and interpretation.
- Support investigations to understand root cause of technical problems.
- Maintain all training requirements for the position while seeking out opportunities for continuous development and growth.
- Serve as technical subject matter expert (in training) for sterilization equiment and process.
Qualifications
- Bachelors degree in Engineering Engineering Technology or related disciplines.
- Minimum of 2 years experience
- Working knowledge of GMP FDA 21 CFRISO 13485 and other ISO regulations pertaining to sterilization.
- Working knowledge of AutoCAD REVIT/BIM or other similar software.
- Proficient in Microsoft Office software (Word excel powerpoint Outlook etc.).
Physical Requirements:
- Ability to travel approximately 20% as necessary to other facilities.
- Work under general office environment conditions.
- Utilize close visual acuity for working with computers and equipment.
- Frequently required to sit stand walk and communicate.
- Occasionally lifting with maximum exertion during shift.
Required Experience:
IC
Key Skills
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
