Medical Device Injection Molding Engineer: Validation

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 460,000 - 854,000; Full time

Job summary

Arni Medica Private Limited in Patancheru, India, is seeking an Injection Molding Engineer to own molding process engineering, mold care and validation for precision medical device components produced in a cleanroom environment.

You will establish robust process windows, lead machine and mold setup standards, drive root-cause analysis of defects, manage preventive maintenance, lead process validation, support new mold trials, ensure GMP/ISOClass7/8 discipline, train technicians and track OEE and

Qualifications

• Diploma or B.Tech in Plastics, Polymer, Mechanical or Production Engineering; CIPET background preferred.
• 4–8 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.
• Strong documentation skills: engineering drawings, measurement systems, validation protocols and reports in English; comfortable with Excel/MIS.

Responsibilities

• 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.

Skills

Injection molding

Process engineering

Validation

Documentation

GMP/Quality systems

Education

Diploma/B.Tech in Plastics/Polymer/Mechanical/Production Engineering

Tools

Arburg

Engel

Toshiba

Haitian

Ferromatik Milacron

Job description

Arni Medica Private Limited in Patancheru, India, is seeking an Injection Molding Engineer to own molding process engineering, mold care and validation for precision medical device components produced in a cleanroom environment.

You will establish robust process windows, lead machine and mold setup standards, drive root-cause analysis of defects, manage preventive maintenance, lead process validation, support new mold trials, ensure GMP/ISOClass7/8 discipline, train technicians and track OEE and