Operator I

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Working under close supervision may perform a combination of assembly and test operations on pacemakers implantable cardioverter defibrillators (ICDs) Hybrids and related medical device assemblies. Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed. Certain problems may be referred to supervisor or more senior level personnel within assigned department.

MAIN RESPONSIBILITIES

• Performs Electronic Assembly functions: Assembles solders and x-rays medical devices and related parts using microscopes and applicable tools;
• Locates and corrects problems by examining and performing visual inspection of parts; Tests units using computerized test equipment.
• Performs Cutting/Coating functions: Examines medical devices and related assemblies after dispense operations to locate bubbles nicks and/or excess epoxy; Patches and repairs bubbles or voids using syringes and small tools; bakes parts to cure epoxy patches.
• May set-up/utilize special test equipment.
• 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.
• 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

Exceptions to be reviewed by HR.

Experience/Background

Typically six plus months of relevant training/experience in the assembly of digital/analog circuitry devices components or equivalent.

Demonstrated manual dexterity and hand/eye coordination. Must be able to use 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 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.

Some formal training in assembly techniques; experience with assembling manufactured items in a bio-instruments/bio-devices related facility. Prior experience working in an air-conditioned clean room manufacturing environment requiring stringent environmental controls.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

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MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: