Summary of the position:

Under the supervision of the Molding Process Engineer:

• You will develop duties and responsibilities such as set up and machinery operation used in injection molding manufacturing, supporting process validation, troubleshooting, repairs, and conducting maintenance (As required and Preventative) on machines, tools, and equipment. Helps ensure quality by making machine and control adjustments, tracking scrap, and making process improvements.

Responsibilities:

1. Collaboration with the Process Engineer and Engineering Management.

a. Set up and maintain production of injection molding machines, tooling, and processes.

b. Support for providing a safe and capable process for production.

c. Collaborate with Engineering to enhance and debug processes, tooling, and new / transfer products

d. Responsible for start-up, process verification, troubleshooting, and root cause analysis of any issues related to injection molding processes or the associated equipment.

e. Management in peripheral equipment (thermoregulators, temperature controllers, dryers, gravimetric mixers, etc.)

f. Accurately performs start-up and shut-down procedures on molding machines and robots.

2. Collaboration with the Quality Engineer and Quality Management.

a. Makes required machine and equipment control adjustments to maintain proper quality and cycle efficiency. Recommends procedural changes to improve machine efficiency and operation.

b. Support in control and quality assurance techniques and measurement instruments.

c. Follows all applicable standard operating procedures, manufacturing instructions, and/or standing instructions.

d. Support in developing the Process Failure Modes and Effect Analysis (PFMEA)

3. Support in the areas of manufacturing, engineering, materials, and quality engineering.

a. Coordinates with the above areas to support start-up, restart-up, or other validation or operation activities requested by manufacturing and engineering.

b. It will keep a record of the process sheet parameters of each machine or production line and will be responsible for providing the necessary information for the closure of the validation or production startup.

c. Follows all validation protocols and submitting parts, as well as the correct filling of the forms for product validation

d. It will give notice to the Quality Engineer about any condition that requires his attention, as well as address any quality issues and give notice of it to the areas involved.

4. Support to quality team on the non-conforming material procedure when finding an out-of-specification product.

5. Participate in environmental training sessions (to which they are invited)

6. Perform their tasks and responsibilities respecting the controls for the care of the environment and the integrity of employees

7. Comply with the activities related to the insurance meter

Requirements for the position:

Education:

• Preferably Plastic Technician, Mechanical Technician or Mechatronic Technician
• Preferably a technical career in a related area (Plastic Injection Molding)
• Training on injection molding process. RJG, Scientific Injection Molding (Mandatory)

Experience:

• Preferably 3-5 years of experience in the injection molding process and tooling (Tooling qualifications and troubleshooting) or equivalent.
• Experience in process validations and process adjustments through IQ, OQ & PQ.
• Experience minimum 2 years in high precision tools and /or medical industry (Preferable)
• Preferably 2-3 years of experience on hot runner systems (husky, Ewikon, Fostag, Incoe, Mold master), high precision tools.
• Experience in handling hydraulic and electrical injection molding machines, preferably in a medical device setting: Krauss Maffei, Engel, Arburg, Fanuc. etc.
• Experience on high runner molds (Cycle time 8 to 12 sec ), multi cavity (32 -64 cav)

Knowledge:

• Knowledge of Process Development method (Scientific Injection Molding or equivalent) (Mandatory)
• Knowledge of different Engineering resins, colorants, and additives (PP,PC,ABS,PS, etc)
• Quality and production requirements (desirable)
• Basic knowledge of PFMEA (Process Failure mode & Analysis) Control Plan (desirable)
• Use of measuring equipment (desirable)
• Interpretation of tolerances in drawings (desirable)
• Knowledge of Client Scientific Monterrey products (desirable)

Skills/Competencies:

• Analytical Skill
• Communication
• Decision making
• Leadership
• Negotiation Skills
• Quality Control/Assurance
• Results Orientation
• Teamwork
• Safety
• Organization/Work in multiple activities
• Ethics
• CAPA
• Technological Tools

Position deliverables:

KPI s:

• Documentation without filling errors
• Correct in-process validations
• Correct start up and documentation for each First Article Inspection
• Process Monitoring Format
• Safe mold installation and check list inspection before and after the installation.