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

Position: Molding Process Engineer Department :Tooling Position Summary: Adroit USA Inc an US based collaborator in developing and manufacturing Class II & III Cannula based medical devices is seeking a Engineer for its Bommasandra, Bangalore location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The Engineer will be responsible for Molding Process development for new products. The ideal candidate will have a strong background in Plastic Injection Molding process along with Scientific Injection Molding (SIM) experience. Job Description: Overall Responsibilities: Establish the process for new products using Scientific Injection Molding (SIM) and maintain process specifications and documentations as per defined SOPs Work on New Molds trials, IQ & PCS, DOE, OQ and PQ. Document the trial feedback details and provide feedback to NPD & Tooling team. Responsible to attend mold trials at Inhouse & supplier places, regular follow ups on Mold development status. Planning of Raw materials for NPD projects and monitoring the stock details. Create the validation protocols for NPD projects Create the Installation Qualification reports for NPD projects & New Injection Molding machines Provide the inputs to improve the mold designs. Involve in the FOT feedback brainstorming and provide the inputs to prove out and first time right(FTR) Identify and investigate potential new tooling concepts and processes. Analyze Moldflow simulation results, implement the solution in a new mold, define the molding process window, and make injection setting parameters based on scientific calculation. Manage the technical part and mold tuning loops from Off Tool to Initial samples and manage the molding DoE. Provide support on new product tooling launch and process at each milestone through production, providing the manufacturing and engineering inputs for the development of new processes, parts, and tooling. Knowledge and Skills: Proficient in Plastic injection molding process and Scientific Injection Molding (SIM) technique Knowledge of quality management systems ISO 13485& Good Manufacturing Practices (GMP). Experience to handle Two plate, Three Plate & Hot Runner molds Have experience with Autodesk Moldflow Simulation and Analysis. Have experience with the Design of Experiments (DoE) and validation protocol (IQ, OQ, and PQ). Accurate, high attention-to-detail, tactful, a fast learner and highly organized is a must. Proactive and persistent team player with a strong passion for collaborative team work. Have good interpersonal, leadership, and conflict-resolution skills. Have superb creativity, logic, vision, and problem-solving skills. Have good communication skills in English, oral and written Knowledge on Robot interface and installing end of arm tooling for Robots will be added advantage. Qualification: Diploma or Bachelor's degree in plastic/mechanical engineering A Minimum of 5 years' experience in Plastic Injection molds process development, preferably in the medical/pharmaceutical industry. Job Function: NPD Molding Process Engineer Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment

Position: Engineer Department: Quality Assurance Position Summary: Adroit USA, an US based collaborator in developing and manufacturing class II & III medical devices is seeking a qualified and detail-oriented QA Engineer for its Bommasandra/Peenya, Bengaluru location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The Engineer is a key member of the site Leadership Team and this role leads the AUSAMD in Bengaluru, supervise the activities of a team of Quality . Job Description: To be able to understand work instructions and perform Basic knowledge in APQP, PDCA, control plan SAP QM SPC 7QC tools. Coordinate with other functions to ensure smooth process of QMS/protocols. Coordinate with other functions to ensure smooth process of QMS/protocols. Visual inspection of final parts after machining and after plating Having knowledge of in process activities Having knowledge of 1st off inspection activities Document control to ensure correct revision levels Monitoring final inspection as per control plan, as per documentation of project Understand the drawings and make sure that all specified points or dimensions are properly inspected to prepare a document. Knowledge of using VMS, Vernier calliper, micrometre, height gauge, slip gauges, plunger dial gauges Profile projector etc. Knowledge in GD&T. Working on ISO 13485 documentations and filings. Inhouse inspection, rejection and rework report, and handling supplier quality issues & in house complaint. Knowledge, And Skills Knowledge in GD&T. Working on ISO 13485 documentations and filings. knowledge in APQP, PDCA, control plan SAP QM SPC 7QC tools. Keywords To be able to understand work instructions and perform. To be able to read write of protocols and the function and follow ups. Good Communication skills Computer Knowledge. Qualification / Experience Diploma in Mechanical Engineering (DME) with 03 Years & Bachelor of Engineering in Mechanical (BE) 2+ years of experience. Job Function: (Incoming & calibration) Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment, Canteen Facility & Medical Insurance. 1 of 2