Manufacturing Engineer

Job Description

Job Description

The Manufacturing / Operations Engineer supports Vein360’s reprocessing and manufacturing operations by improving processes, identifying and implementing equipment and workflow changes, supporting design transfer from R&D, and helping maintain facility and equipment readiness. This role is responsible for identifying bottlenecks, reducing inefficiencies, supporting Lean manufacturing initiatives, and ensuring operational improvements are practical, compliant, and sustainable.

The Manufacturing / Operations Engineer works closely with Operations, Quality, R&D, and production personnel to improve throughput, reduce variation, support equipment and process implementation, and strengthen day-to-day manufacturing execution. This position requires a hands-on individual who is comfortable working on the production floor, observing processes directly, troubleshooting issues, and translating improvement ideas into clear actions for both management and floor-level employees.

This is an on-site role in Blue Ash, OH.

Essential Functions:
· Supports continuous improvement projects within Operations to improve efficiency, throughput, quality, safety, and process reliability.
· Observes production and reprocessing activities on the floor to identify bottlenecks, inefficiencies, workflow constraints, and opportunities for improvement.
· Develops and implements practical process improvements using Lean manufacturing principles and data-driven problem solving.
· Supports design transfer activities from R&D into Operations, including process implementation, equipment readiness, work instruction input, and production floor feedback.
· Assists with identification and implementation, qualification, troubleshooting, and improvement of manufacturing equipment, fixtures, tools, and process aids.
· Supports facility readiness by helping ensure production areas, utilities, equipment, and related infrastructure are maintained in a condition suitable for safe, compliant, and efficient operations.
· Partners with Production leadership to evaluate process flow, workstation layout, material movement, operator usability, and equipment performance.
· Works with Quality to ensure process changes are properly documented, reviewed, approved, and implemented in accordance with applicable procedures and regulatory expectations.
· Supports updates to work instructions, procedures, forms, and training materials related to manufacturing and process improvements.
· Assists in root cause analysis for production issues, equipment problems, nonconformances, rework, or recurring process failures.
· Provides hands-on technical support for production equipment, maintenance needs, troubleshooting, and minor repairs or adjustments as appropriate.
· Communicates improvement ideas clearly to management, production personnel, Quality, and R&D in a manner that supports understanding and adoption.
· Supports automation, robotics, equipment upgrades, and process technology improvements where applicable.
· Maintains accurate and timely records related to projects, process changes, equipment activities, and improvement work.
· Supports a safe, healthy, compliant, and inclusive work environment.
· Performs other duties as assigned.

Minimum Requirements:
Education:
Bachelor’s degree in Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical field preferred. Equivalent technical experience may be considered.

Experience:
2+ years of experience in manufacturing, operations engineering, process engineering, continuous improvement, or a related technical role preferred. Experience in a medical device, FDA-regulated, ISO-regulated, or other regulated manufacturing environment is preferred.

Preferred Skills/Qualifications:
•    Experience with Lean manufacturing, process improvement, workflow optimization, or production support.
•    Experience supporting equipment implementation, troubleshooting, process validation, or design transfer activities.
•    Basic understanding of electrical, pneumatic, mechanical, and automated systems preferred.
•    Experience with automation, robotics, fixtures, tooling, or hands-on equipment improvement is beneficial.
•    Experience working directly with production operators, supervisors, Quality, and Engineering teams.

Working Conditions:

Office environment with frequent sitting, walking, standing, kneeling, and occasional climbing. Lab and production environment, including proper use of appropriate PPE for handling used medical devices. Includes donning of smocks, foot covers, safety goggles, face shield, hair net, and latex free gloves for extended periods of time. Frequent use of hand-eye coordination while using equipment and tools. Visual capacity including depth perception, color vision, and peripheral vision enabling operation of office machinery, laboratory equipment, production equipment, and tools. Light physical effort required by handling objects up to 30 pounds occasionally and up to 15 pounds frequently.

Equal Employment Opportunity Statement

Vein360 is an Equal Opportunity Employer. Employment decisions are based on business needs, job requirements, and individual qualifications. Vein360 does not discriminate on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law.

Vein360 is committed to providing reasonable accommodations to qualified individuals with disabilities in the application process and throughout employment, as required by applicable law.

Disclaimer

This job description and above statements are intended to describe the general nature and level of work performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, qualifications, or working conditions. Duties, responsibilities, and activities may change at any time, with or without notice, based on business needs.