PTCA Balloon Process-Assistant Manager

Job Description:

1. Production & Process Management

• Supervise day-to-day manufacturing of PTCA balloons as per defined SOPs.
• Monitor critical process parameters such as extrusion, balloon forming, pleating, folding, bonding, and assembly.
• Ensure production output meets planned schedules, quality standards, and yield targets.
• Identify and troubleshoot process deviations, implement corrective and preventive actions (CAPA).

2. Quality & Compliance

• Ensure strict adherence to ISO 13485, FDA 21 CFR Part 820, GMP, and internal QMS requirements.
• Collaborate with QA/RA teams during audits, inspections, and validations.
• Maintain accurate documentation of BMR, process records, and change control activities.

3. Process Improvement & Validation

• Lead process optimization, yield improvement, and cost reduction projects.
• Prepare and execute process validation (IQ, OQ, PQ) protocols.
• Support technology transfer and scale-up activities for new balloon designs.

4. People & Training

• Supervise and train operators/engineers in critical manufacturing processes.
• Monitor skill matrix and ensure cross-training to reduce dependency.
• Foster a culture of safety, discipline, and continuous improvement on the shop floor.

5. Cross-functional Collaboration

• Work closely with R&D for product development and pilot builds.
• Support Supply Chain & Planning teams in material availability and production planning.
• Collaborate with Maintenance for equipment upkeep and calibration.

Key Skills & Competencies

• Strong knowledge of PTCA balloon manufacturing processes: extrusion, blow molding, balloon forming, folding/pleating, and assembly.
• Familiarity with polymers and materials used in balloon catheters (e.g., Nylon, Pebax, PET).
• Good understanding of cleanroom operations (ISO Class 7/8).
• Knowledge of statistical process control (SPC), Lean, Six Sigma, and problem-solving tools (8D, RCA).
• Strong leadership, team management, and communication skills.