Role Objective:

A key objective of this role is day-to-day ownership of injection moulding operations for medical device components, including IOL cartridges and injector delivery system parts. The role owns machine and mould performance, output, and operator training, while working within a quality structure where inspection sign-off remains fully independent of this role.

This is a hands-on technical and operational role the Manager is expected to be personally capable of diagnosing process and mould issues (parting-line wear, flash, short shot, cycle-time drift), not solely a supervisory or administrative position.

Desired Candidate Profile:

- B.E./B.Tech in Mechanical, Plastics, Polymer, or Production Engineering (mandatory), with an additional qualification from CIPET or NTTF, or an equivalent recognized plastic /tooling institute (mandatory).
- 812 years of experience in injection moulding operations, with direct, hands-on experience specifically within medical device manufacturing (ISO 13485 environment) this is a requirement for this role, not a preference. General industrial or automotive injection moulding experience, however senior, does not substitute for direct medical device experience: tolerance expectations, documentation discipline, and regulatory context differ materially.
- Direct experience with multi-cavity mould operation, mould changeover, shot-weight and cycle-time control, and recognition of parting-line, flash, short-shot, and weld-line defects.
- Experience running preventive maintenance on a shot-count basis (not calendar-only), and maintaining mould history and cavity qualification records.
- Working knowledge of First Piece Confirmation (FPC) discipline at every startup and mould changeover.
- Familiarity with engineering resins used in medical device moulding (e.g., ULTEM, PEBAX, PC, PP) and their process-sensitivity,



including drying and regrind handling where applicable.
- Working knowledge of ISO 13485 and GMP documentation requirements, sufficient to work effectively with the Quality function without holding inspection or disposition authority.
- Experience supervising shift operators, including training, skill-matrix development, and multi-skilling.
- Strong problem-solving ability, with experience in root-cause analysis for moulding defects.

Key Responsibilities:

1. Moulding Operations Management

- Own day-to-day output, OEE, and shift-level performance across all injection moulding machines at the facility.
- Plan and coordinate mould changeovers to minimize downtime, given the facility's high changeover frequency across its mould register.
- Escalate resourcing, tooling, or capacity constraints to the Value Stream Lead in a timely manner.

1. Mould and Machine Management

- Own preventive maintenance scheduling on a shot-count basis for all active moulds, in coordination with the Mould Maintenance Engineer(s).
- Maintain mould history cards and cavity qualification records for every active mould.
- Ensure First Piece Confirmation is performed and documented at every startup and mould changeover, without exception.

1. Process Control and Defect Prevention

- Monitor shot weight, cycle time, and process parameters against approved process windows for each part.
- Identify and correct root causes of parting-line wear, flash, short shot, and weld-line defects before they affect downstream Assembly.




- Support the QA Engineer's shared FMEA covering Moulding and Assembly defect modes.

1. People Management and Training

- Supervise, train, and develop Shift Incharges and Machine Operators, including cross-training for coverage across the facility's machines.
- Maintain and update the team's skill matrix, including defect-recognition training for operators.

1. Quality and Regulatory Compliance

- Ensure moulding operations comply with ISO 13485 and applicable GMP documentation requirements.
- Work closely with the QC Inspector and QA function on defect trends and corrective actions this role does not hold inspection, rejection, or disposition authority, which remains independent of production at every checkpoint.

Functional Skills:

- Injection Moulding Process Expertise (Medical Device)
- Mould Maintenance and Cavity Qualification
- ISO 13485 Quality Management System Knowledge
- Engineering Resin Processing (ULTEM, PEBAX, PC, PP)
- Shift and Team Supervision
- Root Cause Analysis and Defect Troubleshooting

Behavioral Skills Required:

- Solid attention to detail and process discipline
- Ownership and accountability for shift and machine performance
- Hands-on, floor-based leadership style
- Effective communication with Assembly, Quality, and the Value Stream Lead
- Comfortable operating within, and respecting, an independent quality function

Team Size:

- Reports to: GM Site Head
- Team Structure: 8-10 direct reportees

Important Links:

- Website: https://biotechhealthcare.com/
- LinkedIn: https://www.linkedin.com/company/biotechhealthcare/
- Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, sexual orientation, disability, etc.

📌 Injection Molding Engineer (Ahmedabad)
🏢 Biotech Vision Care
📍 Ahmedabad