Extrusion Manufacturing Engineer II

$57,300 - $114,700/Yr

Abbott Laboratories - Plymouth, MN

Full-time - Mid Level

Plymouth, MN

10,001+ employees

Miscellaneous Manufacturing

About the position

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. This position works out of our Plymouth, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. The Extrusion Manufacturing Engineer II position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. In this role, you will be responsible for the evaluation of production equipment, providing production support, and conducting process validation. You will interface with vendors for incoming components and troubleshoot manufacturing processes and equipment. Utilizing tools like Gage R&R, Cp, Cpk, and SPC will be essential to improve processes. You will also need to understand manufacturing concepts such as Value Stream mapping, 5S, and Visual Workplace to enhance quality, labor efficiency, and throughput. Additionally, you will be tasked with protocol and report writing, generating and modifying manufacturing process documentation, and working with cross-functional teams as required. Your contributions will include developing and implementing process improvements and supporting all company initiatives as identified by management, particularly in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments is crucial. Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors is also a key aspect of this role. You may be required to perform other related duties and responsibilities as assigned.

Responsibilities

• Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules.
• Evaluate production equipment and provide production support and process validation.
• Interface with vendors for incoming components and troubleshoot manufacturing processes 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.
• Write protocols and reports, and generate and modify manufacturing process documentation.
• Work with cross-functional teams as required to develop and implement process improvements.
• Support all company initiatives as identified by management in support of Quality Management Systems (QMS) and Environmental Management Systems (EMS).
• Comply with FDA regulations and other regulatory requirements, company policies, and operating procedures.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• Bachelor's Degree in Mechanical, Industrial, Chemical, Biomedical or related Engineering area, or an equivalent combination of education and work experience.
• Minimum 3 years of demonstrated experience in extrusion, tooling, troubleshooting equipment, and performing machine and process set-ups preferred.
• 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.
• Strong verbal and written communications skills with the ability to effectively communicate at multiple levels in the organization.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice-to-haves

• Experience in the medical device industry.
• Familiarity with FDA regulations and compliance processes.
• Experience with process validation and quality management systems.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and the Freedom 2 Save student debt program.
• FreeU education benefit for an affordable path to getting a bachelor's degree.
• Career development opportunities with an international company.