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
AUSA MEDICAL DEVICES PVT. LTD. Position: NPD-Process Development Engineer Department : NPD-Process Engineering Position Summary: Adroit USA, an US based collaborator in developing and manufacturing class II & III medical devices is seeking a qualified and detail-oriented NPD-Process Development Engineer for its Bommasandra/Peenya, Bengaluru location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The NPD-Process Engineering is a key member of the Team and this role is importantmanage the activities of NPD. Job description: Establish Processes for New product development Validate (IQ, OQ and PQ) processes for new product development Establish Manufacturing documents like RM specifications, MSDS, SOP, PFMEA, Test Methods, Control plan and Visual standards, Work Instructions etc. Prepare Risk Management documents Conduct Test Method Validations (GR&R) Perform Process capability analysis as per customer requirement Analyse design specification and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products Applies technical knowledge to innovate, design and develop the processes, tooling, and equipment. Defines and releases the deliverables as defined by Project plan and Master validation plan Provides design for manufacturing (DFM) input to the assembly and component specifications Compiles and writes training materials, develops and conducts training sessions Works collaboratively with appropriate departments/teams to develop processes, complete validations, and handover to regular production team Estimates production cycle times, resource requirements and related costs to provide information for management decisions Analyses data for process investigation, productivity improvements, cost analysis, regulatory filings; documents and communicates results Purchase order review and contract review related to new product development Review product data sheet and new product development plan Coordinating with CFT team Review of Customer Drawings and Internal drawings for every process Preparing Design of Experiment (DOE) Test Protocols and Report Defines and releases the Installation, Process Characterization, Operational and Performance Qualification (IQ/PCS/OQ/PQ) Test Protocols and Reports Preparing Trial Work Order Preparing FAIR, Incoming, and final inspection reports Preparing Risk Analysis Report Verifying Tools, Jigs and Fixture Preparing Fixture validation reports Preparing Device Master Record and Master validation plan Preparing Re-validation reports Preparing Engineering change request and Document change request Preparing Certificate of conformance and Packing labels for NPD parts Preparing purchasing request Performs other related duties as assigned by the management Qualifications: BE Mechanical Engineering or Bio Medical Engineering and 5+ years of process development/ Improvement experience Demonstrated cross functional team work in technically demanding environment Demonstrated ability to develop processes from concept to production Skills and Knowledge: Highly motivated individual that can independently drive deliverables to completion through collaboration among team members Demonstrated ability to develop and drive innovative solutions into processes and products Problem Solving - Able to identify problems and use Lean tool to solve the problem Proficient in Excel, Word, Power Point and MS office/PC applications Teamwork Able to work cross functions to support for assigned tasks. Attitude Positive thinking and keep learning to improve personal skill. Process capability analysis through Minitab software ISO 13485, Manufacturing of Medical Equipment and Medical regulatory standards Excellent written and oral communication skills Strong organizational and Analytical skills Ability to manage priorities and work flow Demonstrated ability to plan and organize projects Good judgement with the ability to make timely and sound decisions Creative, Flexible, and Innovative team player Working knowledge of data collection, data analysis, evaluation, and scientific method Metrology, GD&T and Measurement Product and Process Data integrity Quality Tools (8D, PFMEA, SPC, MSA) Competencies: Interpersonal Skills- Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things Job Function: NPD-Process Engineering Industry: Medical Devices Manufacturing Industry What's on Offer: Attractive salary package and Friendly environment
Position: Designer Department: Tooling Position Summary: Adroit USA, an US based collaborator in developing and manufacturing class II & III medical devices is seeking a qualified and detail-oriented Mold Designer for its Bommasandra/Peenya, Bengaluru location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The Mold Designer is a key member of the Team and this role is important to manage the activities of Tool Room. Job Description: Position Summary: Overall Responsibilities: Create complete mold design from the component 2D/3D. Create fixtures/jigs design. Do design of experiment, create BOM, DFMEA. Create 3D & 2D drawings for Tool/fixture assembly. Trouble shooting Review part models for moldability, sufficient draft and shut-off conditions Prepare part models for mould design (adding draft, defining parting lines, core & cavity extraction, etc.) Maintain Injection Mould Standards, prepare part drawings from CAD models Transfer files between customers and vendors Experience in plastic injection mould design. Mould filling simulation software knowledge. Creating Electrode Drawings & Stage drawings. Document control to ensure correct revision levels Work with CAD/CAM software Programmer & Toolmakers to optimize mold designs for production Knowledge, And Skills Experience in Two plate, three plate & Hot runner molds. Experience to design Side core mechanism Mold, Dog leg cam mechanism mold & Insert molding. Experience to Design Multi Cavity molds & Family mold. Experience in SolidWorks or other CAD. Experience in Jigs & fixture design. Knowledge in GD&T Qualification: Diploma in Tool & Die Making from GTTC/NTTF. An associate's degree in Mold Design or a related field may be advantageous. A minimum of 3 years' experience in Designing Plastic Injection molds & fixtures. Job Function: Designing Plastic Injection molds & fixtures. Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment 1 | Page
JOB DESCRIPTION Position:Mould Designer Department: Tooling Position Summary: Adroit USA, an US based collaborator in developing and manufacturing class II & III medical devices is seeking a qualified and detail-oriented Mold Designer for its Bommasandra/Peenya, Bengaluru location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The Mold Designer is a key member of the Team and this role is important to manage the activities of Tool Room. Job Description: Position Summary: Overall Responsibilities: Create complete mold design from the component 2D/3D. Create fixtures/jigs design. Do design of experiment, create BOM, DFMEA. Create 3D & 2D drawings for Tool/fixture assembly. Trouble shooting Review part models for moldability, sufficient draft and shut-off conditions Prepare part models for mould design (adding draft, defining parting lines, core & cavity extraction, etc.) Maintain Injection Mould Standards, prepare part drawings from CAD models Transfer files between customers and vendors Experience in plastic injection mould design. Mould filling simulation software knowledge. Creating Electrode Drawings & Stage drawings. Document control to ensure correct revision levels Work with CAD/CAM software Programmer & Toolmakers to optimize mold designs for production Knowledge, And Skills Experience in Two plate, three plate & Hot runner molds. Experience to design Side core mechanism Mold, Dog leg cam mechanism mold & Insert molding. Experience to Design Multi Cavity molds & Family mold. Experience in SolidWorks or other CAD. Experience in Jigs & fixture design. Knowledge in GD&T Qualification: Diploma in Tool & Die Making from GTTC/NTTF. An associate's degree in Mold Design or a related field may be advantageous. A minimum of 3 years' experience in Designing Plastic Injection molds & fixtures. Job Function: Designing Plastic Injection molds & fixtures. Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment
Position: Sr. Design Engineer Department: Design Position Summary: AUSA Medical Devices Pvt. Ltd. Bommasandra plant is seeking a highly skilled and innovative Senior Mechanical Design Engineer with expertise in SPM design, jigs, fixtures, and automation systems. In this role, you will be responsible for conceptualizing, designing, developing, and validating precision engineering solutions that support the manufacturing and assembly of advanced medical devices. The position focuses on delivering custom automation solutions ranging from semi-automated jigs to fully automated SPMs that enhance process reliability, reduce cycle time, and improve manufacturing efficiency. You will collaborate with cross-functional teams including manufacturing, Quality Assurance, and Process development to ensure successful execution of projects from concept to production. This is a critical role where your designs will directly contribute to manufacturing efficiency and product reliability. Job Description: Design & Development Ensure Design and development of automated mechanical systems, SPMs, jigs, and tooling solutions meets process requirements. Lead the team members in concept design development and selection of standard components. Ensure detailed 3D CAD models and engineering drawings to support manufacturing and assembly process to meet the product requirements. Integrate pneumatics, hydraulics, sensors, motion control, and robotics into fixture and machine designs as required. Review and approve design drawings, providing technical feedback to designers & manufacturers. Verification & Testing Verify the designs by performing tolerance stack up analysis, GD&T, and DFX. Demonstrate the design by simulations and analyzes to ensure design reliability (Ex. motion studies). Lead acceptance testing and support trials during installation & troubleshooting. Support process development team on problem-solving by involving root-cause analysis of issues during development phase. Compliance & Documentation Drive compliance with ISO 13485, CE safety standards, and internal quality systems. Ensure designs meet DFM/DFA principles for manufacturability, assembly, and cost-effectiveness. Prepare and maintain technical documentation including design specifications, DFMEA, ECR/ECN, risk assessments, and validation reports. Collaboration & Execution Collaborate with controls/PLC engineers for automation and motion system integration. Work with vendors and process engineers for technical discussions, manufacturability, and sourcing. Partner with cross-functional teams to ensure seamless execution of projects from concept to production. Innovation & Leadership Explore emerging technologies (low-cost automation, IIoT-enabled systems, lean automation) to drive process improvements. Identify opportunities for design optimization, cost reduction, and efficiency gains. Mentor junior engineers and import a culture of innovation, collaboration, and continuous improvement. Knowledge and Skills Proficiency in any CAD software packages. (Preferred: SolidWorks, ZW CAD and AutoCAD). Strong understanding of mechanical engineering principles, materials science, and their application in precision engineering. Familiarity with Selection of automation system components such as pneumatics, hydraulics, sensors, servo/stepper motors, and robotics. Advanced knowledge of GD&T, tolerance stack-up analysis, and precision manufacturing practices. Experience with simulation and analysis tools (motion/kinematic analysis) is a plus. Basic knowledge of manufacturing processes including machining (Turning Milling, Grinding, Laser Cutting), Bulk Forming (MIM, forging), metal forming (Bending, punching, blanking, stamping, deep drawing, roll forming), plastic molding, Extrusion and additive manufacturing. Excellent problem-solving, analytical, and root cause analysis skills. Strong collaboration, communication, and technical documentation abilities. High attention to detail with a strong commitment to quality, safety, and regulatory compliance (ISO 13485, CE/OSHA). Ability to manage multiple projects while meeting the tight timelines. Qualification B.E./B.Tech in Mechanical or Mechatronics Engineering (PGDIA preferred). 7+ years experience in SPM design, automation fixtures, or tooling projects (SPM Automation preferred). Exposure to pneumatics, hydraulics, servo/stepper systems, and PLC integration. Proficiency in SolidWorks/AutoCAD with strong GD&T knowledge. Strong grasp of mechanical systems, materials, and manufacturing processes. Excellent problem-solving, analytical, and team collaboration skills. Job Function: Sr. Design Engineer -New Product Development Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment
Position: NPD-Process Development Engineer Department : NPD-Process Engineering Position Summary: Adroit USA, an US based collaborator in developing and manufacturing class II & III medical devices is seeking a qualified and detail-oriented NPD-Process Development Engineer for its Bommasandra/Peenya, Bengaluru location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The NPD-Process Engineering is a key member of the Team and this role is importantmanage the activities of NPD. Job description: Establish Processes for New product development Validate (IQ, OQ and PQ) processes for new product development Establish Manufacturing documents like RM specifications, MSDS, SOP, PFMEA, Test Methods, Control plan and Visual standards, Work Instructions etc. Prepare Risk Management documents Conduct Test Method Validations (GR&R) Perform Process capability analysis as per customer requirement Analyse design specification and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products Applies technical knowledge to innovate, design and develop the processes, tooling, and equipment. Defines and releases the deliverables as defined by Project plan and Master validation plan Provides design for manufacturing (DFM) input to the assembly and component specifications Compiles and writes training materials, develops and conducts training sessions Works collaboratively with appropriate departments/teams to develop processes, complete validations, and handover to regular production team Estimates production cycle times, resource requirements and related costs to provide information for management decisions Analyses data for process investigation, productivity improvements, cost analysis, regulatory filings; documents and communicates results Purchase order review and contract review related to new product development Review product data sheet and new product development plan Coordinating with CFT team Review of Customer Drawings and Internal drawings for every process Preparing Design of Experiment (DOE) Test Protocols and Report Defines and releases the Installation, Process Characterization, Operational and Performance Qualification (IQ/PCS/OQ/PQ) Test Protocols and Reports Preparing Trial Work Order Preparing FAIR, Incoming, and final inspection reports Preparing Risk Analysis Report Verifying Tools, Jigs and Fixture Preparing Fixture validation reports Preparing Device Master Record and Master validation plan Preparing Re-validation reports Preparing Engineering change request and Document change request Preparing Certificate of conformance and Packing labels for NPD parts Preparing purchasing request Performs other related duties as assigned by the management Qualifications: BE Mechanical Engineering or Bio Medical Engineering and 5+ years of process development/ Improvement experience Demonstrated cross functional team work in technically demanding environment Demonstrated ability to develop processes from concept to production Skills and Knowledge: Highly motivated individual that can independently drive deliverables to completion through collaboration among team members Demonstrated ability to develop and drive innovative solutions into processes and products Problem Solving - Able to identify problems and use Lean tool to solve the problem Proficient in Excel, Word, Power Point and MS office/PC applications Teamwork Able to work cross functions to support for assigned tasks. Attitude Positive thinking and keep learning to improve personal skill. Process capability analysis through Minitab software ISO 13485, Manufacturing of Medical Equipment and Medical regulatory standards Excellent written and oral communication skills Strong organizational and Analytical skills Ability to manage priorities and work flow Demonstrated ability to plan and organize projects Good judgement with the ability to make timely and sound decisions Creative, Flexible, and Innovative team player Working knowledge of data collection, data analysis, evaluation, and scientific method Metrology, GD&T and Measurement Product and Process Data integrity Quality Tools (8D, PFMEA, SPC, MSA) Competencies: Interpersonal Skills- Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things Job Function: NPD-Process Engineering Industry: Medical Devices Manufacturing Industry What's on Offer: Attractive salary package and Friendly environment
Position: Metrology - Inspector / Metrology - 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 Metrology Inspector for its Bommasandra/Peenya, Bengaluru location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions. The Metrology Inspector 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 Assurance.Job Description: Knowledge in Reading and understanding of manufacturing drawings, Preparation of Inspection Reports. Knowledge on Measuring Instruments Knowledge on GD&T Symbols. Knowledge on measurement using Profile Projector, Micro Vu and CMM. Knowledge, And Skills Inspecting the parts by using measuring instruments like Caliper, Micrometer, Height gage, Plug gage, Thread gage, Ring gage etc. Inspecting the parts by using Micro Vu Preparing First Article Inspection/Layout Inspection Report Conducting Variable & Attribute Inspections Preparing Inspection Report for Validation Preparation First of Inspection Report Preparing & Running Microvu Program Inspection of parts for Validation, Inspection of parts for Incoming, In process and Final Quality Parts 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: ITI / Diploma in Mechanical Engineering (DME) with 02 Year & above Job Function: Metrology - Inspector / Metrology - Engineer Industry: AUSA Medical Devices Private Limited What's on Offer: Attractive salary package and Friendly environment