PTCA Balloon Process-Operator

Job Description:

We are looking to hire PTCA Balloon Process-Operator (Medical Devices) for our organization with the following details:

General Requirements for All Operators

• Qualification: 1–4 years of experience in medical device manufacturing / cleanroom operations preferred.
• Ability to work in ISO 7/8 cleanroom with gowning discipline.
• Basic computer literacy for recording process data.
• Willingness to work in shifts and handle repetitive tasks with accuracy.

1 Balloon Forming Operator

Responsibilities:

• Operate and monitor balloon forming machines as per validated parameters.
• Handle extrusion tubing and ensure correct loading/alignment.
• Inspect balloon dimensions (ID, OD, wall thickness, length) using gauges/microscope.
• Record process data in BMR/DHR accurately.
• Escalate any deviations or machine abnormalities to supervisor.

Skills:

• Knowledge of polymers (Nylon, PET, Pebax).
• Basic understanding of heating, pressure, and molding processes.
• Good eyesight and hand–eye coordination for micro-level inspection.

 2 Balloon Pleating & Folding Operator

Responsibilities:

• Operate pleating/folding equipment for balloon profile reduction.
• Verify pleat uniformity and folding quality under microscope.
• Maintain tool cleanliness and calibration before use.
• Handle balloons with care to avoid contamination/damage.

Skills:

• Attention to detail and patience for repetitive, delicate tasks.
• Ability to use micro-gauges, profile testers, and magnification tools.

3 Balloon Bonding / Welding Operator

Responsibilities:

• Perform precision bonding of balloon to catheter shaft (proximal/distal).
• Operate laser/thermal bonding machines as per SOP.
• Check bond strength through pull test and visual inspection.
• Maintain bonding jigs, tools, and workstations in validated condition.

Skills:

• Steady hands and fine motor skills.
• Familiarity with thermal/laser bonding techniques.

4. Balloon Assembly Operator

Responsibilities:

• Assemble catheter sub-components (shaft, marker bands, balloon, hub).
• Perform leak tests, inflation/deflation cycle checks.
• Verify assembly alignment and functional integrity.
• Document each step in production records.

Skills:

• Understanding of catheter components and handling requirements.
• Ability to follow detailed work instructions.

5. Hydrophilic Coating Operator

Responsibilities:

• Operate coating machine/dip coating setup as per SOP.
• Prepare coating solutions and ensure proper filtration/viscosity.
• Perform surface pre-treatment and drying under controlled conditions.
• Check coating uniformity, adhesion, and functionality.
• Maintain EHS (environmental, health, safety) standards for chemical handling.

Skills:

• Knowledge of solvent handling and safety (chemical PPE use).
• Familiarity with coating thickness measurement and inspection.