Production Engineer

Job Title:

Engineer - Production

Department:

Manufacturing

Location:

Vapi, Gujarat

Reports To:

Manager / Senior Manager – Manufacturing

Job Purpose:

To ensure efficient and compliant plastic manufacturing operations for medical devices by managing production planning, process execution, material control, and vendor coordination across injection moulding, extrusion, and thermoforming processes in line with GMP and ISO 13485 requirements.

Key Responsibilities:

1. Production Planning & Execution

• Plan and execute daily production schedules to achieve output targets.

• Ensure production adherence to approved plans and delivery timelines.

• Monitor machine utilization and drive productivity improvements.

• Coordinate manpower allocation for smooth shop-floor operations.

• Minimize downtime through effective planning and coordination.

2. Material Planning & Inventory Control

• Maintain and update daily raw material status reports.

• Ensure availability of materials as per production requirements.

• Plan and maintain optimum inventory levels aligned with customer demand.

• Coordinate with SCM for timely procurement and replenishment.

3. Process Management (Moulding & Extrusion)

• Operate and optimize injection moulding, extrusion, and thermoforming processes.

• Ensure process stability for medical-grade plastic components.

• Handle micro-moulding operations for precision components.

• Monitor process parameters and ensure consistent product quality.

• Support process validation and continuous improvement initiatives.

4. Cleanroom & Regulatory Compliance

• Ensure operations in cleanroom environments (Class 100K to 10K) as per protocols.

• Maintain compliance with GMP and ISO 13485 standards.

• Support adherence to biocompatibility requirements (USP Class VI, ISO 10993).

• Ensure compliance with sterilization processes (ETO, Gamma) where applicable.

5. Quality Coordination & Process Control

• Coordinate with QA for in-process and final inspections.

• Identify and address process deviations and non-conformances.

• Support implementation of corrective and preventive actions (CAPA).

• Ensure adherence to technical drawings, tolerances, and specifications.

6. Vendor Management & Development

• Develop and manage suppliers for polymers, moulds, and consumables.

• Conduct vendor audits and performance evaluations.

• Ensure quality and consistency of incoming materials.

• Identify and maintain alternate suppliers for critical materials.

7. Documentation & Reporting

• Maintain production records in line with ISO 13485 documentation requirements.

• Ensure accurate reporting of production output, material usage, and process parameters.

• Support traceability and batch record maintenance.

• Participate in internal and external audits.

8. Continuous Improvement & Productivity Enhancement

• Identify opportunities for process optimization and cost reduction.

• Drive initiatives to improve OEE, yield, and cycle time.

• Support new product introduction (NPI) and scale-up activities.

• Implement best practices for lean manufacturing and waste reduction.

Qualifications and Experience:

• Bachelor's degree in mechanical / production (CIPET preferred).

• 3–5 years of experience in plastic manufacturing / injection moulding operations.

• Experience in medical device or regulated manufacturing environment preferred.

Skills and Competencies:

• Strong knowledge of injection moulding, extrusion, and thermoforming.

• Hands-on experience with medical-grade polymers (PP, PE, PTFE, PS, PC).

• Ability to read technical drawings and understand tolerances.

• Understanding of cleanroom operations and contamination control.

• Knowledge of GMP, ISO 13485, and regulatory compliance.

• Exposure to sterilization methods (ETO, Gamma).

• Strong planning, coordination, and problem-solving skills.

• Good communication and cross-functional collaboration ability.

Key Performance Indicators (KPIs):

• Achievement of daily and monthly production targets.

• Improvement in OEE, productivity, and machine utilization.

• Reduction in process defects and rejections.

• Accuracy of material planning and inventory control.

• Compliance with GMP, ISO 13485, and audit requirements.

• Effectiveness in vendor management and material quality.

• Contribution to continuous improvement and cost optimization initiatives.