Injection Molding Production Engineer

Job Description

Position Production Sr. Engineer/Engineer Department Production Position Summary: AUSA Medical Devices Private Limited, part of Adroit USA Inc an US based collaborator in developing and manufacturing Class II & III Cannula based medical devices is seeking a Sr. Engineer/Assistant Manager for its Bommasandra, Bangalore location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The Sr. Engineer/Assistant Manager will be responsible for executing and monitoring the planned production requirements without compromising on the quality requirements alongside works on process development for new products coming in. Initiate continuous improvements in our manufacturing process and successfully implement them. The ideal candidate will have a strong background in Plastic Injection Molding process along with Scientific Injection Molding (SIM) experience and a passion for producing high-quality components. Job Description: Overall Responsibilities: Demonstrate technical knowledge and technical know-how on Plastic Injection Molding process and provide solutions for any process related issues. Work on trial/sample production, IQ & PCS, OQ and PQ production. Document the trial production details and provide feedback to NPD team. Establish the process for new products using Scientific Injection Molding (SIM) and maintain process specifications and documentations as per defined SOPs. Evaluate process cycle time, process setup/changeover time and process capability for both new products and production, provide feedback & initiate any process/product changes needed. Evaluate and communicate available production capacity and manpower for production planning. Monitor and optimize the production capacity and manpower corresponding to production volumes. Plan overtime of manpower in case any criticality/surge in production requirements. Monitor and optimize the overtime of manpower utilized. Plan and facilitate consumable items used in production. Monitor and optimize the usage of consumables corresponding to production volumes. Ensure that all process inputs are available to run the production. Provide interim action in case of any issues related to process inputs. Ensure that production schedule/plan is being followed. Plan for interim action in case of any concerns. Record any gaps in the schedule/plan for analysis & improvement. Ensure batch records of production are completed inline to the production completion date. Ensure traceability & identification of products and clean/controlled room requirements are maintained in the shopfloor as per the defined SOPs. Monitor and analyze production data, Machine utilization, Machine OEE and WIP. Work on monthly Production reports, WIP reports, MIS reports, ERP activities as per the requirements of the organization. Identify and plan for training needs of production team members. Coordinate and provide training for the team members as per the identified training needs. Communicate any incoming quality issues/ in-process quality issues to the internal stakeholders and QA team and follow the interim actions initiated. Meet the internal rejections target during production. Document & Analyze the internal rejections and work on corrective & preventive actions as needed. Communicate any Machine/Line breakdowns to Maintenance team & initiate interim actions. Plan for the alternatives to meet the production requirements if needed. Plan, execute and document continual improvements on productivity, quality and cost on the shop floor by involving the needed team members. Work on the closure of internal Non-Conformances (NCs) and customer complaints by finding the root cause and corresponding corrective and preventive actions. Knowledge and Skills: Proficient in Plastic injection molding process and Scientific Injection Molding (SIM) technique Knowledge of quality management systems (e.g., IATF 16949, ISO 13485) & Good Manufacturing Practices (GMP). Able to manage injection molding production team independently. Strong technical aptitude with attention to detail. Effective communication and interpersonal skills for cross-functional collaboration. Analytical mindset for data interpretation and process improvement. Self-motivated and capable of managing multiple tasks simultaneously. Qualification: Diploma or Bachelors degree in plastic/mechanical engineering Have about 4 of work experience in Injection molding production and process development, preferably in the medical/pharmaceutical industry. Job Function: Production Injection Molding Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment