Injection Molding Engineer - Medical Devices

Arni Medica Pvt Ltd.; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Arni Medica Private Limited in Hyderabad, a medical devices and IVD manufacturer, seeks an Injection Molding Engineer to own molding process engineering, mold care and validation for precision components in a cleanroom.

You will establish process windows, lead machine/mold setup standards, and drive root-cause analysis with CAPA. The role requires 4–8 years in injection molding, with GMP/ISO13485 discipline and strong documentation in English.

Qualifications

• Diploma or B.Tech in Plastics, Polymer, Mechanical or Production Engineering.
• 4–8 years in injection molding with process engineering and validation exposure.
• Experience in medical device/IVD molding is an advantage.
• Proficient in English documentation and data recording.

Responsibilities

• Establish robust process windows; document parameters for each mold and material.
• Lead machine and mold setup standards for hydraulic, electric & hybrid machines.
• Drive troubleshooting and CAPA for molding defects and downtime.
• Own preventive/predictive maintenance for medical device molds.
• Lead IQ/OQ/PQ, mold qualification trials, and first article inspection.
• Support new mold trials, product transfers and mold design reviews with toolmakers.
• Ensure GMP and ISO Class 7/8 discipline; maintain DHR records.
• Train technicians and monitor OEE, rejection and downtime for continuous improvement.

Skills

Injection molding

Process engineering

Mold maintenance

Validation IQ/OQ/PQ

GMP/ISO13485 knowledge

Root-cause analysis

Documentation (English)

Education

Diploma in Plastics/Polymer/Mechanical/Production

B.Tech in plastics/polymer/mechanical/production

CIPET background preferred

Tools

Excel/MIS

Job description

Arni Medica Private Limited, an ISO 13485:2016 certified medical devices and IVD manufacturer at the Medical Devices Park, Hyderabad, is hiring Injection Molding Engineers to own molding process engineering, mold care and validation for precision medical device components manufactured in a cleanroom environment.

• Establish robust, repeatable process windows using scientific/decoupled molding principles; define and document process parameters for every mold and material.
• Lead machine and mold setup standards: changeover procedures, startup/shutdown sequences and settings sheets for hydraulic, electric and hybrid machines with auxiliary equipment.
• Drive troubleshooting and root-cause analysis (5-Why, fishbone) of molding defects, dimensional drift, cycle time losses, rejection and unplanned downtime; implement corrective and preventive actions.
• Own the preventive and predictive maintenance program for medical device molds: PM schedules, hot runner and ejector system maintenance, cavity/core polishing standards, spare parts planning, mold history and shot-count tracking; manage external toolroom repairs.
• Lead process validation (IQ/OQ/PQ), mold qualification trials, first article inspection and capability studies with QA/RA; support CAPA, deviations and change control for molding processes.
• Support new mold trials, new product introductions and mold transfers; review mold designs (cooling, venting, gating, hot runners) with toolmakers for manufacturability and maintainability.
• Ensure GMP and cleanroom (ISO Class 7/8) discipline, line clearance, 5S, LOTO and machine safety; maintain DHR-linked records per ISO 13485.
• Train and supervise technicians and operators on machine handling, process discipline and mold care; track OEE, rejection and downtime metrics and drive continuous improvement.

Qualifications

• Diploma or B.Tech in Plastics, Polymer, Mechanical or Production Engineering; CIPET background preferred.
• 4 to 8 years in injection molding, including process engineering, mold maintenance and validation exposure.
• Experience in medical device, IVD or other precision/cleanroom molding is a strong advantage.
• Working knowledge of medical grade polymers (PP, PE, ABS, PC, PVC, TPE) and machines such as Arburg, Engel, Toshiba, Haitian or Ferromatik Milacron.
• Strong documentation skills: engineering drawings, measurement systems, validation protocols and reports in English; comfortable with Excel/MIS.