Vascular Manufacturing Engineer – PCB & Process Improvement

Thornton Tomasetti; Saint Paul (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Tuition reimbursement

Health insurance

Retirement plan

Job summary

Abbott seeks a Manufacturing Engineer to support sustaining activities for FFR and OCT hardware in the Vascular division. This on-site role in St.

Paul MN involves layout, construction, and evaluation of prototype PCBs, fixtures, and tools, applying engineering principles to solve technical problems. The position requires 3+ years in PCB/layout, familiarity with FDA regulations, and strong communication and team collaboration.

Qualifications

• Bachelor of Science in electrical/electronic engineering or related engineering field.
• A minimum of three (3) years of relevant work experience in layout construction, and evaluation 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/concentration desired.
• 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-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.

Responsibilities

• 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.

Job description

Abbott seeks a Manufacturing Engineer to support sustaining activities for FFR and OCT hardware in the Vascular division. This on-site role in St.

Paul MN involves layout, construction, and evaluation of prototype PCBs, fixtures, and tools, applying engineering principles to solve technical problems. The position requires 3+ years in PCB/layout, familiarity with FDA regulations, and strong communication and team collaboration.