Key Responsibilities: Create and update 2D and 3D CAD models and engineering drawings using SolidWorks. Maintain accurate CAD databases and revision-controlled design files in accordance with Quality Management System (QMS) protocols. Generate and maintain Bill of Materials (BOMs) for all products and design configurations. Support the Design History File (DHF) compilation by providing up-to-date drawings, BOMs, and release records. Ensure proper version control, file storage, and change documentation in alignment with document control procedures. Process Engineering Change Requests (ECRs) and execute Engineering Change Orders (ECOs) with appropriate drawing updates. Participate in design reviews, perform CAD documentation updates, and review drawing checklists for accuracy and completeness. Maintain traceability of design records across design input, output, verification, and validation stages. Collaborate with Quality Assurance (QA) to ensure all CAD deliverables meet internal standards and regulatory requirements (ISO 13485, FDA 21 CFR Part 820). Provide necessary design documentation and CAD records during internal and external audits. Support prototype and production teams by delivering precise and manufacturable CAD files and drawings. Communicate cross-functionally with R&D, QA, Manufacturing, and Regulatory teams. Required Qualifications: Diploma/Degree in Mechanical Engineering, Biomedical Engineering, or related field. 3+ years of experience in a CAD engineering role within a medical device or precision engineering company; orthopedic implant experience preferred. Expertise in SolidWorks and AutoCAD (3D modeling, assemblies, drafting, GD&T, drawing templates, etc.). Strong knowledge of engineering drawing standards (ASME Y14.5, ISO) and tolerancing practices. Familiarity with PLM/PDM systems and CAD data management tools. Understanding of Design Control principles, DHF documentation, and regulatory requirements for Class II/III medical devices. Hands-on experience with ECR/ECO processes and BOM management. Knowledge of manufacturing processes, particularly CNC machining, casting, and surface treatments relevant to orthopedic implants. Proficient in drawing review, revision tracking, and model history documentation. Detail-oriented, with strong analytical and organizational skills. Ability to work both independently and in a team-oriented environment. Nice to have hands on: Experience with Additive Manufacturing and FEA simulations is a plus. Familiarity with ISO 13485, FDA Design Control regulations, and CE/USFDA design documentation standards. Experience supporting audit processes (Notified Body, FDA, Internal) from a CAD/documentation perspective. Key Tools & Documents: SolidWorks, AutoCAD (2D/3D Modeling) Drawing Review Checklists Engineering Change Requests (ECRs) & Engineering Change Orders (ECOs) Bill of Materials (BOMs) DHF Drawing Contribution Records CAD Model Revision Logs Verification and Validation Evidence Document Control Systems (PDM/PLM)
Company Name: Alkem MedTech Ortho Private Limited. Purpose of the role: The Engineering and Facilities Lead is responsible for overseeing and managing all engineering and facilities operations within the organization. This includes ensuring the safe, efficient, and compliant operation of the companys facilities, including shopfloor, laboratories, and office spaces. The role involves leading a team to maintain and improve facilities systems, equipment, and infrastructure, ensuring that all operations meet regulatory standards, safety requirements, and operational efficiency targets. Roles & Responsibilities: Facilities Management & Operations: Oversee the day-to-day operations of all company facilities, ensuring compliance with safety, environmental, and regulatory standards (e.g., FDA, GMP, OSHA). Manage facility maintenance programs, including preventive and corrective maintenance schedules, to ensure the smooth operation of all systems (HVAC, electrical, plumbing, etc.). Ensure the integrity of all infrastructure (e.g., building structures, equipment, utilities) and coordinate repairs or upgrades as needed. Maintain a clean, safe, and efficient work environment, ensuring facilities are compliant with regulatory standards and industry best practices. Engineering Support & System Optimization: Provide engineering expertise and support to optimize facility systems, equipment, and processes. Identify opportunities for process improvement, energy savings, and cost reduction across engineering and facilities operations. Ensure the proper functioning and calibration of critical equipment used in manufacturing and testing processes, aligning with the companys quality control and regulatory requirements. Lead engineering projects related to facility upgrades, new construction, or equipment installations, ensuring timelines and budgets are met. Regulatory Compliance & Safety: Ensure that all facilities, equipment, and systems comply with relevant regulatory guidelines (e.g., FDA, GMP, environmental regulations). Implement and maintain safety protocols to ensure a safe working environment for all employees, including hazardous material management and emergency response plans. Lead risk assessments and implement corrective actions to mitigate any safety or operational risks within the facilities. Prepare and support internal and external audits and inspections, ensuring all necessary documentation is in place for regulatory compliance. Capital Projects & Budget Management: Lead and manage capital projects related to facility improvements, expansions, or new installations, ensuring adherence to project plans, timelines, and budgets. Develop and manage the facilities and engineering budget, ensuring cost-effective use of resources and identifying cost-saving opportunities. Evaluate and recommend investments in new technologies or infrastructure improvements to increase efficiency and meet business objectives. Sustainability & Environmental Initiatives: Develop and implement sustainable practices for energy use, waste management, and resource conservation in the facilities. Work with environmental health and safety teams to ensure compliance with local environmental laws and regulations. Drive initiatives to reduce the companys environmental footprint and improve overall sustainability within engineering and facilities operations. Emergency Preparedness & Crisis Management: Ensure the implementation of robust emergency response plans and procedures, including power outages, system failures, or facility incidents. Lead the crisis management team during any facilities-related emergency, coordinating response efforts and ensuring timely resolution.
Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future. Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector. We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you. Why Join Us? Innovation-Driven Environment : Work on cutting-edge technologies in precision and implantable medical devices. Growth Opportunities : Be part of a strategic growth initiative for one of the leading pharmaceutical companies and be part of creating a legacy. Collaborative Culture : Engage with a team of dedicated professionals committed to making a difference in healthcare. Impactful Work : Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond. Manufacturing in India : Support the vision of the Government of India by contributing to domestic production and innovation in the MedTech sector. Join us at Alkem MedTech and help shape the future of healthcare technology. Purpose of the role: The Microbiologist is responsible for ensuring the sterility of orthopedic knee and hip joint implants, monitoring microbiological processes, conducting microbiological testing, and ensuring compliance with relevant standards and regulations. This role involves conducting environmental monitoring, sterilization validation, and contamination control to ensure product safety and quality. Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples in accordance with GMP (Good Manufacturing Practices) and ISO standards. Conduct sterility testing, endotoxin testing, and bioburden testing of implants and related materials. Monitor and maintain environmental controls in cleanrooms, including air, surface, and personnel monitoring. Validate sterilization processes (e.g., Ethylene Oxide, Gamma Radiation) and perform routine sterilization cycle monitoring. Investigate microbial contamination events and implement corrective and preventive actions (CAPA). Maintain microbiological laboratory instruments, ensuring calibration, validation, and proper maintenance. Prepare detailed reports on microbiological findings, test results, and environmental monitoring data. Ensure compliance with regulatory requirements including FDA, ISO 13485, and EU MDR. Provide microbiological support during audits and inspections by regulatory bodies. Develop and review microbiological standard operating procedures (SOPs) and test protocols. Train and mentor junior staff on microbiological procedures and aseptic techniques.