Supervisor, Device Assembly

Cook Group•West Lafayette, IN

About The Position

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

Requirements

Minimum BS, or MS degree preferred, in Health or Life Sciences, Engineering or related Industry
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.

Nice To Haves

Knowledge of MED Institute Device Assembly process, preferred
Knowledge of MED Institute Quality System procedures, preferred

Responsibilities

Maintain APT training logs for production/QC
Supervise clean-room and 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-room and 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