26309 Miles Road, Warrensville Heights, OH, USA
Duties and Responsibilities: In this role, the individual will be primarily responsible for the direct manufacturing of medical devices including (but not limited to):
- Handling and manipulation of xenograft tissue, including inventory management, measuring tissue size and mechanical treatment
- Mixing and labeling chemical solutions used to process the tissue
- Placing the tissue in treatment baths and moving the tissue between different treatment baths
- Measuring, cutting and packaging the product
- Printing and application of package labeling
- Tracking supply inventory levels
- Boxing and shipping product
- Performing quality checks of the product at the appropriate points in the manufacturing process
- Cleaning and sterilizing the equipment and supplies used in the manufacture of the product
- Maintaining required manufacturing records and documentation per the expectations of a traditional medical device
- Setting up, operating, and maintaining equipment
- Comply with FDA Good Manufacturing Practice guidelines
- A High School Diploma/GED is required
- A 2-year technology degree in engineering or other scientific field is highly desirable.
- The ability to communicate effectively, both verbally and in writing
- The ability to read, understand and perform technical procedures written in the English language.
- Attention to detail and the ability to complete the paperwork required for medical device manufacturing.
- The ability to perform liquid volume and mass measurements.
- Basic proficiency in Microsoft Word, Excel and Outlook
- Previous experience working at a tissue bank, medical device company or meat processing facility is desirable.
Language Skills: Candidate must have the ability to read, analyze and interpret general technical procedures and government regulations written in the English language. Must also be able to effectively respond to questions from groups of managers, clients, and auditors in the English language.
Work Environment: A majority of the individual’s time will be spent in the manufacturing area, which consists of a mix of cleanroom and lab-style manufacturing spaces. Functions will be performed in both a sitting and standing position at times. When in the cleanroom, the individual will be expected to wear designated gowning and follow standard anti-contamination practices. All areas are environmentally controlled.
Hours of Operation: 7:00am-3:30pm Monday-Friday
Benefits: Viscus Biologics offers a competitive insurance package including but not limited to medical, dental, vision, paid time off, paid holidays, as well as retirement options.
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