Manufacturing Engineering Technician

Otsuka ICU Medical LLC

Austin (TX)

On-site

USD 85,000 - 115,000

Full time

3 days ago

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Job summary

Otsuka ICU Medical LLC is seeking a Manufacturing Floor Engineer who will be the primary engineering resource on the production floor, delivering daily technical support to Manufacturing and Maintenance. The role focuses on equipment reliability, process stability, and uninterrupted production while maintaining cGMP compliance and safety.

Responsibilities include root cause analysis, implementing sustainable improvements, coordinating with Maintenance, Quality, Validation, Automation, and

Qualifications

Must have hands-on mechanical troubleshooting skills.
Experience with manufacturing and packaging equipment preferred.
Knowledge of RCA, FMEA, and reliability engineering principles.

Responsibilities

Provide technical guidance to maintenance on troubleshooting and repairs.
Investigate chronic equipment issues and implement permanent fixes.
Support validation, commissioning, and upgrades of equipment on the production floor.
Collaborate with cross-functional teams to improve uptime and process reliability.
Ensure compliance with cGMP, FDA, OSHA and company standards.

Skills

Mechanical troubleshooting

Manufacturing equipment

Root Cause Analysis

Equipment reliability

Communication

Education

Bachelor's degree in Mechanical/Electrical/Industrial Engineering

Tools

CMMS

Maintenance planning

Job description

JOB DESCRIPTION

The Manufacturing Floor Engineer is the primary engineering resource assigned to the production floor, providing daily technical support to Manufacturing and Maintenance to ensure equipment reliability, process stability, and uninterrupted production. This position spends the majority of the workday in the manufacturing areas, working directly with operators, mechanics, technicians, and supervisors to resolve equipment issues, improve machine performance, reduce downtime, and ensure manufacturing systems operate safely and compliance with cGMP and company standards.

Position Summary

The Floor Engineer is responsible for identifying chronic equipment problems, participating in root cause investigations, implementing sustainable engineering solutions, and coordinating with Maintenance, Quality, Validation, Automation, and Engineering to improve equipment performance and manufacturing efficiency.

Essential Duties And Responsibilities

Daily Manufacturing Support

Serve as the first-line engineering support for assigned manufacturing and packaging areas.
Maintain a visible presence on the production floor throughout the shift to support operations.
Respond to equipment issues that require engineering analysis beyond routine maintenance.
Work closely with Production and Maintenance to restore equipment safely and efficiently while minimizing downtime.
Participate in daily production meetings and maintenance shift handoffs to communicate equipment status and priorities.
Monitor production performance and proactively identify opportunities to improve equipment reliability and efficiency.

Equipment Reliability

Investigate recurring equipment failures and implement permanent corrective actions.
Conduct Root Cause Analysis (RCA) investigations into chronic equipment problems and production interruptions.
Analyze equipment performance using downtime reports, OEE, MTBF, MTTR, reject rates, and production metrics.
Identify equipment modifications that improve reliability, maintainability, safety, and operational performance.
Support development and optimization of preventive and predictive maintenance strategies.

Maintenance Support

Provide technical guidance to maintenance mechanics and technicians during troubleshooting activities.
Assist Maintenance with complex mechanical, electrical, pneumatic, hydraulic, and process-related issues.
Review completed work orders to identify recurring failures and recommend corrective actions.
Support equipment startups following maintenance activities or repairs.
Verify equipment operates within design specifications before returning it to production.

Continuous Improvement

Identify and recommend improvements that reduce downtime, increase equipment availability, and improve product quality.
Support Lean Manufacturing, TPM, and Continuous Improvement initiatives.
Recommend engineering changes that simplify maintenance and improve equipment accessibility.
Participate in kaizen events and cross-functional improvement projects.

Compliance and Documentation

Ensure equipment modifications comply with cGMP, FDA, OSHA, and company engineering standards.
Support investigations, deviations, CAPAs, and change controls related to manufacturing equipment.
Collaborate to help Develop and revise equipment procedures, troubleshooting guides, and maintenance documentation.
Maintain accurate engineering records and technical documentation.

Validation and Projects

Support commissioning, qualification, and validation of new or modified equipment.
Assist with Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and startup activities.
Participate in engineering projects affecting assigned manufacturing areas while maintaining daily operational support.
Provide technical input for equipment upgrades and capital improvement projects.

Training and Collaboration

Train operators and maintenance personnel on equipment operation, troubleshooting, and best practices.
Work closely with Production, Maintenance, Quality, Validation, Automation, Facilities, and Engineering teams.
Using your technical knowledge, collaborate with maintenance personnel on equipment improvements.

Other Responsibilities

Participate in after-hours troubleshooting when required.
Support shutdowns, startups, and emergency maintenance activities.
Perform other engineering duties as assigned.

Knowledge, Skills, And Qualifications

Strong hands-on mechanical troubleshooting skills.
Working knowledge of manufacturing and packaging equipment.
Understanding of mechanical systems including pumps, motors, gearboxes, conveyors, bearings, pneumatic systems, and process equipment.
Basic understanding of electrical controls and PLC-controlled equipment.
Knowledge of Root Cause Analysis (RCA), FMEA, and reliability engineering principles.
Ability to interpret engineering drawings, equipment manuals, and technical documentation.
Familiarity with CMMS systems and maintenance planning.
Strong analytical, organizational, and communication skills.
Ability to prioritize multiple equipment issues in a fast-paced manufacturing environment.
Ability to work under limited supervision while supporting cross-functional teams.

Required

Education and Experience

Bachelor's degree preferred in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or a related engineering discipline.
Minimum of two (2) years of experience supporting manufacturing equipment in an industrial environment.

Preferred

Associate degree or technical degree in Mechanical, Electrical, Industrial, Manufacturing, Automation, or a related technical discipline.
Bachelor's degree in engineering or a related discipline may be considered a preferred qualification.
Experience in a regulated manufacturing environment.
Experience in pharmaceutical, biotechnology, medical devices, or other regulated manufacturing environments.
Experience working closely with maintenance organizations.
Experience supporting equipment validation, commissioning, and continuous improvement initiatives.

Minimum Qualifications

Must be at least 18 years of age.
Ability to lift up to 45 pounds.
Ability to wear required Personal Protective Equipment (PPE).
Ability to work in manufacturing and cleanroom environments.

Physical Requirements And Work Environment

Approximately 90-100% of the workday is spent on the manufacturing floor.
Frequent standing, walking, climbing, bending, kneeling, and working around operating production equipment.
Work is performed in cGMP manufacturing and cleanroom environments.
Frequent interaction with operators, mechanics, technicians, supervisors, and engineering personnel.
Ability to occasionally lift and move materials, equipment, or tools weighing up to 45 pounds.
May be required to support off-shift operations, emergency troubleshooting, equipment startups, and plant shutdowns.

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger - a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants

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