JOB DESCRIPTION
Position: Production Engineer – Extrusion
Department: Production / Manufacturing
Industry: Medical Device Manufacturing
Experience: 4–6 Years
Qualification: B.Tech / B.E. – Mechanical / Polymer / Plastics Engineering
Location: Hyderabad, Telangana
Salary: ₹35,000 – ₹45,000 per month
Employment Type: Full-Time
Job Summary
We are looking for an experienced Production Engineer – Extrusion with strong hands-on experience in polymer extrusion and medical tubing manufacturing.
The candidate will be responsible for managing extrusion production, setting and monitoring process parameters, troubleshooting extrusion defects, achieving production targets, maintaining product quality, and ensuring compliance with ISO 13485 and medical device manufacturing requirements.
Key Responsibilities1. Extrusion Production
- Manage day-to-day production activities related to medical tubing extrusion.
- Operate and monitor extrusion machines and associated equipment.
- Set and optimize extrusion process parameters such as:
- Barrel temperature
- Die temperature
- Screw speed
- Line speed
- Melt pressure
- Puller speed
- Cooling parameters
- Vacuum and sizing parameters
- Ensure production output meets approved specifications and production targets.
- Monitor machine performance and minimize downtime.
2. Medical Tubing Manufacturing
- Experience in manufacturing precision medical tubes/catheters will be preferred.
- Handle thermoplastic materials such as TPU, PVC, PE, PP, PA, TPE and other medical-grade polymers.
- Understand tubing specifications including OD, ID, wall thickness, concentricity, ovality, and dimensional tolerances.
- Ensure proper material handling and traceability of medical-grade raw materials.
3. Process Troubleshooting
Identify and resolve extrusion-related problems such as:
- OD/ID variation
- Wall thickness variation
- Ovality
- Concentricity issues
- Surface defects
- Die lines
- Bubbles
- Melt fracture
- Material contamination
- Inconsistent dimensions
- Poor cooling/sizing
- Process instability
- Conduct Root Cause Analysis (RCA) and implement corrective actions.
- Support process improvement initiatives to reduce rejection, scrap, and rework.
4. Quality & ISO 13485 Compliance
- Ensure production activities are performed according to approved SOPs, Work Instructions, Batch Manufacturing Records, and Process Specifications.
- Maintain complete and accurate production documentation.
- Follow medical device quality requirements and ISO 13485 procedures.
- Support investigations related to deviations, non-conformances, CAPA, and customer complaints, when required.
- Ensure product and process traceability throughout manufacturing.
5. Process Validation & Improvement
- Support process validation, equipment qualification, extrusion trials, and new product development activities.
- Participate in process optimization and continuous improvement projects.
- Develop and maintain process parameter sheets.
- Establish and monitor critical process parameters.
- Work with R&D and Quality teams during new product trials and process transfers.
6. Production Planning & Manpower
- Plan daily extrusion production according to the production schedule.
- Allocate operators and technicians based on production requirements.
- Monitor operator performance and productivity.
- Train operators on machine operation, process parameters, SOPs, and safety requirements.
- Ensure production targets are achieved without compromising quality.
7. Documentation & Reporting
Maintain and review:
- Daily production reports
- Batch records
- Machine parameter records
- Downtime reports
- Rejection and rework reports
- Material consumption records
- Process trial reports
- Production KPI reports
Prepare daily/monthly reports on production, rejection, productivity, downtime, and material wastage.
Required Skills
- Strong hands-on experience in plastic/polymer extrusion.
- Good knowledge of medical tubing extrusion and precision extrusion processes.
- Strong understanding of thermoplastic materials and their processing characteristics.
- Good knowledge of extrusion machines, dies, tooling, sizing, cooling, and puller systems.
- Strong troubleshooting and problem-solving skills.
- Knowledge of ISO 13485 and medical device manufacturing practices.
- Knowledge of 5S, Kaizen, Lean Manufacturing, and continuous improvement.
- Good knowledge of MS Excel and production reporting.
- Good communication and team-management skills.
Job Type: Full-time
Pay: ₹35,000.00 - ₹45,000.00 per month
Benefits:
- Cell phone reimbursement
- Health insurance
- Provident Fund
Work Location: In person
