Manufacturing Engineering Technician

Otsuka ICU Medical•Austin, TX

2d•Onsite

About The Position

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. 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.

Requirements

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.
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.
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.

Nice To Haves

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.

Responsibilities

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