About this role
Overview of Responsibilities:
- Follow rigorous clean room practices for working inside certified clean room assembly areas
- Assemble finished medical devices and medical device components per work instructions
- Inspect and test medical devices per documented visual inspection requirements and inspection plans
- Accurately fill out forms such as travelers and component reconciliation forms
- Enter inspection and testing data into SPC software where required
- Label product with medical device labeling, install instructions for use, warranty cards, etc. into device packaging
- Laser mark traceability information on product
- Operate automated medical adhesive dispensing equipment and other various assembly equipment
- Operate tray sealing and pouch sealing equipment and inspect for packaging integrity
- Wipe down/clean workstations at prescribed intervals
- Perform medical washing operations where required
- Use microscope and/or vision system for complex inspections per work instructions
- Consistently meet product quality requirements and throughput rate expectations
- Assist in providing part specific training for Manufacturing Associates who are not trained on specific item numbers (ongoing)
- Responsibility to protect Donatelle confidential information and Intellectual Property
- Follow safety requirements as outlined in the safety manual
- Perform other projects and duties as assigned
Preferred Qualifications:
Education/Experience:
- 1+ years of relevant experience assembling medical devices in a clean room environment
- High school diploma or GED preferred
Other Qualifications and Desired Skills:
- High attention to detail
- Good dexterity and ability to assemble components of varying sizes
- Good comprehension of written and verbal instruction and be able to articulate these instructions to others when training
- Work with minimal supervision
- Understanding of cGMPs and ISO standards
- Understanding of the importance of proper line clearance
- Ability to use computer for entering of inspection and test data