Supervisor, Device Assembly

MED Institute is a Cook Group company that supports researchers medical device companies manufacturers and consultants through the key phases of product development between the start of an idea and making a product available to clinicians and patients. With more than 30 years of experience in medical device testing data analysis and global regulatory submission preparation our team knows what it takes to guide a product through all the complex steps required for market.

The Device Assembly Supervisor will be responsible for supervising and facilitating assembly of non-clinical and clinical devices for client projects at MED Institute.

• Maintain APT training logs for production/QC
• Supervise clean-roomand controlled environment room
• Coordinate weekly floor cleanings
• Coordinate monthly room cleanings
• Maintain cleaning logs
• Supervise production
• Inventory management
• Keep an accurate count of hardware and components
• Coordinate raw material check in
• Ensure items are cleaned prior to being stored in clean-roomand items in staging area are cleaned and moved into the controlled environment room
• Schedule assign and supply APTs for assembly
• Coordinate QC of APTs
• Complete or coordinate QC of items in QC quarantine
• Complete or coordinate QC of frame mesh and handle builds (require in-process QC)
• Ensure completed APTs go to QC for document control and lot number log is completed
• Shipping and receiving
• Coordinate packaging and shipping of items to be sent to vendors for processing
• Coordinate receipt of items returning from vendors and introduction into inventory
• Sterilization
• Coordinate sterilization runs with vendors as needed.
• Receive items back from sterilization as needed
• Finishing and Shipping
• Maintain open APTs
• Coordinate finished packaging as necessary
• Coordinate shipment of devices to client
• Ensure completion of APTs

• Minimum BS or MS degree preferred in Health or Life Sciences Engineering or related Industry
• Knowledge of MED Institute Device Assembly process preferred
• Knowledge of MED Institute Quality System procedures preferred
• Ability to assume responsibility for and understand the gravity of producing devices that may be used in humans or in testing to support regulatory submissions
• High level of personal integrity
• Ability to recognize problems that can be solved oneself versus problems that should be escalated to management
• High level of accuracy
• Teachable positive attitude with a genuine willingness to learn
• Excellent people/relational skills
• Qualified candidates must be legally authorized to be employed in the United States. MED Institute does not intend to provide sponsorship for employment visa status (e.g. H-1B or TN) for this employment position.