Job objective:This position is responsible for bridging the gap between R&D innovation and mass production. By mastering the technical complexities of medical-grade polymers and precision engineering, this role ensures the facility produces zero-defect, life-saving surgical devices on time and within cost parameters.
Role and Responsibilities- Technical Production & Material Mastery: Focuses on overseeing polymer processing (extrusion/molding), optimizing Golden Run production parameters for quality and consistency (wall thickness, strength), troubleshooting shop-floor issues, and managing high-precision tooling.
- Operational Leadership & Planning: Covers coordinating shift schedules, directing cleanroom operators, implementing Lean methods to improve yield and reduce scrap of high-cost polymers, coordinating capacity planning, and managing Preventive Maintenance (PM) and calibration to ensure zero equipment downtime.
- Cleanroom & Quality Compliance (Core Responsibility): Emphasizes absolute adherence to ISO 13485 and CDSCO standards (Audit-Ready status), enforcing stringent cleanroom discipline (ISO Class 7/8), supervising real-time material traceability via Batch Manufacturing/Production Records (BMR/BPR), and leading IQ/OQ/PQ validation activities.
- R&D Liaison & Innovation Support: Involves collaborating on Design for Manufacturing (DFM) feedback, conducting pilot production runs for new devices, and managing product preparation for ETO/Gamma sterilization while ensuring packaging integrity.
Key Result Areas (KRAs)- Production & Yield: Focuses on maximizing efficiency (OEE), material utilization, minimizing high-value polymer scrap (Pebax/PTFE), and meeting production schedules.
- Quality & Compliance: Emphasizes continuous audit readiness (ISO 13485, CDSCO), ensuring 100% accurate Batch Manufacturing Records (BMR) for traceability, and strict enforcement of sterile zone protocols (e.g., ISO Class 7/8).
- Engineering & R&D: Involves defining Golden Parameters for product consistency, collaborating on Design for Manufacturability (D-F-M) with R&D, and overseeing calibration and preventive maintenance of high-precision equipment.
- Safety & Workforce: Covers implementing comprehensive operator training for technical and sterile processes, and maintaining a Zero Accident culture through strict adherence to HSE protocols.
Key Performance Indicators (KPIs)- Yield Efficiency: Reduce the internal rejection rate of polymer-based products by optimizing machine parameters and cooling cycles.
- Compliance Integrity: Ensure zero deviations in Batch Manufacturing Records during internal quality audits.
- Technical Lead Time: Successfully complete the validation (IQ/OQ/PQ) of any new machinery or mold within the projected timeline.
- Inventory Accuracy: Maintain a 100% match between physical floor-stock of medical-grade raw materials and system records.
Qualifications and Education Requirements- B.E. Polymer/Plastics.
- 5+ Years MedTech Exp
- Familiarity with Strict sterile environments.
- ISO 13485 Knowledge
- Essential for passing audits and global scaling.
- CAD/SolidWorksMediumNeeded to bridge the gap with the R&D team
Preferred Skills- Good communication skills in English, Marathi and Hindi.
- Organizational and multitasking skills.
- Proficiency in MS Office (Excel, Word, Outlook).
- Leadership: Ability to manage and train a workforce of operators and technicians.
- Mumbai-Based/Local: Preference for candidates residing in or around Mumbai to ensure proximity to the manufacturing facility for shift management.
- Professional attitude, punctuality, and willingness to work in a collaborative environment.
Note:- Candidates residing near the office location (Taloja MIDC, 410208, Maharashtra, India) will be given preference.
- Immediate hiring.
- Language preference: English, Marathi & Hindi.
