PTCA Balloon Process-Assistant Manager

PTCA Balloon Process-Assistant Manager

1 Nos.
117982
Full Time
3.0 Year(s) To 8.0 Year(s)
Not Disclosed by Recruiter
Production / Quality / Maintenance
Medical Devices & Equipment
Any - Any Graduation
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).
  1. 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.
  1. 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.
  1. 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.
  1. 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.
Key Skills :
Company Profile

It is, an ISO 9001: 2015 and an American Petroleum Institute (API) Member company, is one of industry leaders in the design and manufacture of Specialty Heat Recovery equipments, Distillation Trays & Internals, Dampers and Guillotines. With approvals from most of the process licensors and end-users globally, --- products include Air Preheaters, Column Trays & Internals, Dampers, Guillotines, Shut-off Blades and Igniters supplied to Oil Refineries, Petrochemical, Power, Fertilizer and Chemical Plants. --- is proud of its quality conscious workforce, a well equipped fabrication shop and a completely automated foundry plant located in Haryana, India, about 125 miles

Telephonic Interview Available

  • Telephonic interview are scheduled for this job opening.
  • Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
  • Candidates can call recruiter on given contact to start telephonic interview during working hours.

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