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Operate and set up automated manufacturing platforms — including robotic feeding, assembly, dosing, transfer, sealing/welding, labeling, and vision-inspection stations — to produce components in compliance with GMP and quality requirements. Perform format and tooling changeovers, calibrate and align mechanical, pneumatic, and electronic subsystems, and monitor process parameters through HMI/PLC interfaces to meet OEE, scrap, and production volume targets. Diagnose and resolve technical faults using structured root-cause methodologies to minimize downtime and interpret vision-system and process alarms in coordination with the Automation and Process Engineering teams. Maintain accurate batch records (DHR) and quality documentation, and report nonconformances and process deviations per established quality systems.

Support

Engineering and Quality during validation, calibration, and troubleshooting activities to ensure consistent, compliant product output.

Essential Functions and Accountabilities (must be able to perform the essential functions with or without accommodation) Identify the principal responsibilities, essential functions, and accountabilities of the position. Each should give an understanding of the purpose of the work and the results to be accomplished, rather than how the function is performed. List the “what”, “how” and “why” of each responsibility and provide examples, as necessary.

Use specific verbs of action, such as, “manages”, “develops”, analyzes”, etc. list job duties that reflect the position requirements.

Technical Operation and Process Control

- Operates the automated platform in line with efficiency (OEE), scrap, and production volume targets.
- Uses the human-machine interface (HMI) to select recipes/formats, monitor system status, enter or adjust authorized parameters, and extract/export process data.
- Performs purges, start-ups, and controlled shutdowns, ensuring the integrity of equipment components and systems.

Mechanical Adjustments and Tooling Changeover (Setup/Changeover)

- Executes format and tooling changes, adjusting precision mechanical settings at assembly, dosing, transfer, and packaging stations.
- Calibrates and aligns ultrasonic sealing/welding stations, electric and pneumatic actuators, and labeling/printing systems.
- Coordinates setup with versátil feeding systems (e.g., vibratory bowls, Asyril-type platforms) and verifies load-cell and sensor readings.





Fault Diagnosis and Root Cause Analysis

- Identifies, diagnoses, and resolves technical faults (mechanical, pneumatic, vision, or sensor-related) to minimize downtime.
- Applies structured problem-solving methodologies (5 Whys, Ishikawa/fishbone diagrams, 8D) to reduce recurrence on the line.
- Assists in interpreting vision-system alarms (false rejects, failed reads) and reports deviations to the Automation Engineering team.

Quality and Regulatory Compliance (GMP)

- Strictly follows SOPs, batch records (Device History Record – DHR), and quality documentation under GMP/ISO 13485 requirements.
- Notifies and documents nonconformance events or process deviations per established quality systems.
- Understands that in-line inspection and test data (e.g., dimensional, pull/weld strength, or vision-verified attributes) feed directly into the product DHR and disposition, and immediately reports anomalies in this data to Quality/Engineering.

Line Preparation, Safety, and Housekeeping

- Performs line clearance, cleaning, and start-of-shift checks in accordance with site SOPs before running production.
- Wears required personal protective equipment and follows machine safety devices, emergency-stop procedures, and lockout points.
- Reports tooling wear or equipment conditions that may affect product quality to the Team Leader/Manufacturing Engineer as soon as identified.

Minimum Education Requirements Identify the required minimum education which would develop the knowledge, skills and abilities described above, which would enable a new team member to perform the job. Remember to include any required licenses or certifications.

- High school diploma or equivalent required; technical/vocational certification (e.g., industrial technician, mechatronics, electromechanics) preferred.
- Prior experience (3-5 years) operating automated or semi-automated manufacturing equipment in a regulated environment (medical device, pharmaceutical, or similar) preferred.

Knowledge, Skills & Competencies

Minimum experience requirements necessary to perform the job. What critical knowledge,



competencies are needed to successfully perform this position (e.g., PC/technology skills, sales experience, demonstrated leadership, etc.).Include aptitudes that are required as well as those that are desirable, e.g., in-depth knowledge of accounting procedures, public speaking skills, ability to work independently. Add any specific language requirements and travel expectations.

- Working knowledge of GMP requirements (21 CFR 820, 210, 211) and basic medical device quality concepts (DHR, batch records, in-process controls).
- Mechanical aptitude for tooling changeover (dies, gripper lugs, hoppers, counter-blades) using hand tools and torque-controlled fasteners.
- Robotics & Feeding: operating knowledge of SCARA robots and flexible feeding platforms (e.g., Asyril or similar).
- Machine Vision: operational understanding and basic diagnostics of industrial vision systems (e.g., Cognex, Keyence).
- Pneumatics & Electromechanics: ability to read basic diagrams and adjust electric actuators, pneumatic cylinders, pressure sensors, and load cells.
- Special Processes: experience with ultrasonic welding and thermal-transfer printing/industrial labeling equipment is desirable.
- Systems & Data: intermediate to advanced use of HMI/PLC interfaces at a technical/recipe-user level, Microsoft Office/Excel for data handling, and familiarity with SQL databases or exported files (CSV).
- Analytical and methodical thinking: logical ability to trace the root cause of a component fault without improvising.
- High-precision attention to detail: essential when handling small/micro-components (e.g., needles, sutures, or similar parts) and making fine mechanical adjustments.
- Strict adherence to process: discipline to follow every step in regulated medical-quality environments without shortcuts.
- Clear technical communication: able to give precise feedback to Maintenance and Process Engineering, and to escalate issues effectively.
- Bilingual Spanish/English preferred, given English-language equipment interfaces/documentation and a Spanish-speaking production floor.
- Ability to follow written work instructions precisely and work independently on routine, repetitive setup and operating tasks.
- Willingness to work within a controlled/clean room manufacturing environment and to wear required gowning/PPE.Willingness to work within a controlled clean room environment and to wear required gowning/PPE.
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📌 Automated Systems Operator Technician (Tijuana)
🏢 Corza Medical
📍 Tijuana