Manufacturing Engineer II

COMPANY PROFILE:

For more than 100 years, the name Terumo®has been synonymous with innovative medical devices. From its start as a manufacturer of clinical thermometers, Terumo has grown worldwide to a position of leadership in such areas as hollow fiber technology, blood management systems, and the creation of new technologies in endovascular therapy.

Terumo has distinguished itself as a high quality manufacturer of medical products, operating four factories and 38 sales branches in Japan, as well as 31 other locations. The company generates annual sales of approximately $6 billion and employs 20,000 people worldwide.

Terumo is an Equal Opportunity Employer

LOCATION: Elkton, Maryland

TITLE: Engineer II, Manufacturing Engineer

BASIC RESPONSIBILITIES:

Job Summary:

The Engineer II - Manufacturing Engineer position is responsible for ensuring the successful day-to-day operation and continuous improvement of a dedicated endovascular medical device manufacturing process within the Terumo Medical Corporation (TMC) Elkton, MD facility. In this role, the manufacturing engineer serves as a technical expert for the manufacturing process they are assigned to. Involved with leading small to medium size projects requiring engineering resources or a multi-discipline team effort.

Job Details:

1. Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned production process and related business continuity needs. Troubleshoot manufacturing process and equipment.

2. Work with Quality Engineering and Production personnel in the conduct of root cause analyses of process non-conformances and implementation of corrective actions.

3. Research and implement cost reduction projects.

4. Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment / product to ensure proper operation of the equipment.

5. Provide assistance to production as required.

6. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.

7. Participate in project team meetings in order to provide ideas, methods, or processes for performance improvement.

8. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

9. Lead small to medium size cost reduction projects, lines, extensions, and/or products which includes overseeing other department personnel during the project.

10. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders.

11. Performs other job related duties assigned.

QUALIFICATIONS:

Background Experience

• BS in Engineering or other related technical field.
• Career progression of 3 or more years of experience with manufacturing equipment and/or processes.
• Experience with manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements a plus.

Knowledge, Skills and Abilities (KSAs)

• Demonstrated ability to design, specify, assemble and validate manufacturing equipment and processes varying from simple to medium complexity.
• Demonstrated ability in the use of critical thinking, problem solving and analysis.
• Understanding of the use of statistical experimental design and analysis techniques, Statistical Process Control (SPC), Six Sigma principals and tools and problem solving and decision-making tools.
• Effective communication skills, both verbal and written.

Job Types: Full-time, Permanent

Pay: From $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Elkton, MD 21921: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Work Location: In person