Operator II

MAIN PURPOSE OF ROLE

Working under general supervision in accordance with specific procedures and practices, may perform a combination of assembly, weld, x-ray, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, electronic systems, and related medical device assemblies. Performs routine assignments with detailed instructions. Follows general instructions for routine work and more detailed instructions for new or special activities. Performs assignments of moderate complexity; usually refers more complex problems to immediate supervisor, lead or more senior level personnel from within the assigned department.

MAIN RESPONSIBILITIES

• 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.
• 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.
• May set-up/utilize special test equipment.
• May provide assistance in expediting priority product and tasks in assigned areas.
• Notifies supervisor of the need to replenish supplies/materials and of any production difficulties that cannot be readily corrected.
• Performs other related duties as directed or assigned Performs other related duties as directed or assigned.
• Support 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.

QUALIFICATIONS

Education

• High School Diploma / GED

Experience/Background

• Minimum 2 years of Relevant training/experience in the assembly of digital/analog circuitry, devices, components or equivalent.
• Minimum 1 year of Experience must include at least one year in the bio-medical field or experience working in an air-conditioned clean room manufacturing environment requiring stringent environmental controls. Demonstrated manual dexterity and hand/eye coordination.
• Demonstrated use of standard hand tools used in the assembly of bio-instruments/bio-devices. Incumbents are required to work cooperatively and productively with others.
• Must be able to multi-task and rotate through all jobs performed in the assigned work group as needed. Incumbents must also be able to meet deadlines on multiple projects.
• Incumbents are required to have demonstrated spelling, punctuation, grammar, basic math/numerical, organizational skills, and a familiarity with standard manufacturing/office equipment and procedures. The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech and demonstrated comprehension skills. The ability to successfully pass a reading comprehension pre-employment examination is mandatory.
• The demonstrated ability to understand and comply with applicable Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential. Must be able to maintain regular and predictable attendance; the ability work overtime is also required.
• Must have the ability to on occasion lift up to approximately 25 pounds.
• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Strong organizational and follow-up skills, as well as attention to detail.Ability to maintain regular and predictable attendance.Regularly scheduled overtime is a requirement of this position.