Operator I

The Opportunity

This position works out of our Liberty, SC location in the Cardiac Rhythm Management Division.

What You’ll Work On

• Performs Electronic Assembly functions: Assembles, welds, solders and x-rays medical devices and related parts using microscopes and applicable tools; Locates and corrects problems by examining x-rays and performing visual inspection of parts; Repairs and tests units using computerized test equipment.
• Performs Casting/Coating functions: Examines medical devices and related assemblies after molding operations to locate bubbles, nicks and/or excess epoxy; Utilizes small drills, reamers, taps and knives to access bubbles and remove excess epoxy; Patches and repairs bubbles or voids using syringes and small tools; bakes parts to cure epoxy patches.
• Performs Mechanical Assembly functions: Kits, assembles, bonds coats and processes medical devices and related parts using microscopes and applicable tools; Locates and corrects problems by examining devices and components and visually inspecting parts/assemblies; Repairs and corrects devices and related components using microscopes and applicable tools.
• May set-up/utilize special test equipment.
• Performs Packaging Functions: Kits, assembles and packages devices and related accessories using applicable tools; Locates and corrects problems using microscope and applicable tools; Reviews all device documentation for completeness and accuracy. Notifies supervisor of the need to replenish supplies/materials and of any production difficulties that cannot be readily corrected.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Works with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
• Works in a production or air-conditioned clean-room manufacturing environment; requires gowning attire to maintain a particle free environment. Low to moderate noise level. Minor exposure to chemicals.
• May work at a desk or workstation.
• Activities require a significant amount of time standing and/or sitting at a workstation, walking to and from different workstations, and in interaction with other assembly, inspection, engineering and production personnel.
• Significant use of hands and arms plus finger dexterity to lift, hold, insert, reach, point and otherwise use and operate instruments, devices and equipment, plus good eye-hand coordination. Use of voice and hearing are important in discussions with other co-workers.
• Requires clear vision (correctable) in reading instruments and devices, plus reading of blueprints, specifications, operation sheets/procedures, and related production documents. May on occasion lift up to approximately 25 pounds.

Required Qualifications

• High School Diploma/GED
• Electronic assembly experience preferred
• Good hand-eye skills and mechanical aptitude
• Able to work with close supervision when in training and then with moderate supervision once competent
• Basic computer skill knowledge
• Working knowledge of GMP and ISO Standards preferred
• Ability to interpret and understand production documents and drawings to complete tasks