Disposable Sustaining Engineer

Job description

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

JOB DESCRIPTION:

Job Summary:

This position will be a sustaining engineering position supporting the FFR and OCT catheter portion of our business.

Job Duties:

• Support all sustaining activities around catheter manufacturing including end of life, supplier change requests, Global compliance standards, IFU/Label changes, support of regulatory submissions, corporate programs, literature review, and all supporting quality system elements

• The position will also support the following manufacturing elements:

• Production support and process validation

• Interface with vendors for components

• Troubleshoot manufacturing process and equipment

• Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes

• Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.

• Protocol and report writing

• Generate and modify manufacturing process documentation

• Work with cross functional teams as required

• Develop and implement process improvements

• 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.

• Performs other related duties and responsibilities, on occasion, as assigned.

Equipment:

Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.

• Knowledge of plastics and wire products and processing
• Experience with fiber optics is beneficial
• Working knowledge of catheter processing equipment is beneficial

Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Qualifications:

• Mechanical, Industrial, Chemical, Biomedical, etc. Engineering degree required.

• 3-5 years of manufacturing engineering experience required.

• Previous medical device experience preferred.

• 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.

• Multitasks, prioritizes and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 25%, including internationally.

• Ability to maintain regular and predictable attendance.

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

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