Manufacturing Engineer

Manufacturing EngineerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.The OpportunityWe are seeking a Manufacturing Engineer for our Vascular division in either St. Paul, MN or Westford, MA. This role is fully onsite role.Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.Job Summary:This position will be a sustaining engineering position supporting the FFR and OCT hardware portion of our business. Performs the layout, construction, and evaluation of a variety of prototype Printed Circuit Boards, fixtures, and tools. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective and cost-efficient practices to execute processes; continually evaluates their effectiveness and appropriateness.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 elementsThe position will also support the following manufacturing elements:Production support and process validationInterface with vendors for componentsTroubleshoot manufacturing process and equipmentUtilize tools like Gage R&R, Cp, Cpk, and SPC to improve processesUnderstand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.Protocol and report writingGenerate and modify manufacturing process documentationWork with cross functional teams as requiredDevelop and implement process improvementsSupport 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 analog electronicsExperience with fiber optics is beneficialWorking knowledge of laser equipment is beneficialCapital equipment experience is preferredWorks primarily in a standard office environment with air conditioning, good lighting with a low to moderate noise level. May also visit research labs, testing labs, production and other areas as well as vendor facilities as necessary.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:Bachelor of Science in electrical/electronicengineering or related engineering field.A minimum of three (3) + years of relevant work experience in performing the layout construction, and evaluation of a variety of Printed Circuit Boards, fixtures and tools.Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks.Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.Advanced credential or professional certification in a relevant discipline/concentrationdesired.Six-Sigma knowledge and experience desired.Training and experience in manufacturing processes and methods desired, especially in the manufacturing of medical devices.Experience working in a broader enterprise/cross-divisionbusiness 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.