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3.0 - 8.0 years

5 - 8 Lacs

Bengaluru

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We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation to completion, ensuring adherence to regulatory standards and internal protocols. 2. Design study plans and methodologies that are scientifically sound and aligned with project objectives, including the selection of appropriate analytical techniques and equipment. 3. Coordinate with cross-functional teams, including project managers, chemists, and quality assurance personnel, to ensure effective study execution and communication. 4. Review and approve study protocols, analytical methods, and reports to ensure accuracy, compliance, and scientific integrity. 5. Provide technical expertise and guidance related to chemical characterization, including the interpretation of analytical data and results. 6. Ensure that all studies are conducted in compliance with Good Laboratory Practice (GLP) and other relevant regulations. 7. Manage study budgets and timelines, identifying potential risks and implementing mitigation strategies to ensure successful project delivery. 8. Train and mentor staff on appropriate methodologies and regulatory requirements related to chemical characterization studies. 9. Participate in project meetings, presenting study findings and progress updates to stakeholders, and incorporating feedback into study design and implementation. 10. Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting chemical characterization and related fields. 11. Facilitate communication with regulatory agencies as needed, providing data and documentation to support submissions and inquiries. 12. Contribute to the continuous improvement of departmental processes and methodologies, ensuring best practices are followed in study design and execution.

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6.0 - 10.0 years

7 - 11 Lacs

Hyderabad

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Job title: Expert Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. About you: Experience: 6 - 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Languages: Verbal and written fluency in English Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

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5.0 - 8.0 years

14 - 15 Lacs

Noida, Greater Noida

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" Jubilant Bhartia Group Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Position Organization- Jubilant Pharmova Limited Designation - Sr. Research Scientist / Research Scientist IPR Location- Gr. Noida Job Summary: The role will be responsible for facilitating a robust Patent strategy and compliance on various aspects of a Medical Device and Artificial Intelligence (AI) technologies with proactive support for on IP due diligence and protection of the intellectual property assets of the organization. Role involves conducting thorough research and analysis of IP issues, to ensure freedom to operate in jurisdictions of business interest, Patentability searches, preparing drafting and filing of new Patent applications for US, EU and CA market, and ensuring compliance with relevant IP Patent laws and regulations in countries of business interest. Key Responsibilities. .. Review and design IP strategy on Drug Device and Artificial Intelligence (AI) products and technologies from engineering perspective and carry out in-house Freedom to operate (FTO)/Infringement Analysis (IA). Drafting of Patent opinions and reports for markets like USA, Europe and Canada. To support R&D, Portfolio, Business, Project Management and Regulatory affairs team from IP s perspective Carry out Patentability studies, drafting and facilitate filing and grant of new Patent publications new and to address various Patent office s technical and administrative queries facilitate nurture innovation culture on assigned projects by identifying new ideas and technical solutions from IP s perspective To Track new Patent publications of competitors in markets like USA, EU and CA Facilitate Development of a robust IP strategy and IP compliance on various aspects of a medical device and AI technologies Person Profile . Qualification - B.Tech /M.Tech (Preferably in Electronics or CS) /PG Diploma in Patents OR/ Registered Indian Patent Agent) Experience 5-8- Yrs in electronics/AI OR Drug device technology based industry Must Have - Familiarity with IP regulatory guidelines and industry best practices for Medical Devices. Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. ",

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2.0 - 6.0 years

0 Lacs

maharashtra

On-site

As a Biomedical Engineer at our company, you will be responsible for performing comprehensive Functional and Performance Testing of ICU ventilators and other respiratory devices to ensure they meet quality and safety standards before delivery. Your role will involve troubleshooting and resolving any technical issues that arise during testing and assisting the R&D Team in testing the software. You will also be required to document the test findings and prepare reports. Your duties will include providing production support to ensure that production is not hindered by quality testing procedures. You will play a key role in maintaining company quality standards and assisting in maintaining the required quality management systems such as ISO 13485 and ICMED 13495 in accordance with regulatory requirements. Additionally, as part of your responsibilities, you will provide technical support to customers and end-users, assisting in troubleshooting and repairing medical devices. You will also contribute to the ongoing maintenance and calibration of devices. Furthermore, you will be responsible for preparing and maintaining all necessary documentation such as user manuals, design specifications, and test reports. Your contributions to regulatory submissions will be crucial in ensuring compliance with industry standards. The ideal candidate for this position should hold a degree in Biomedical Engineering (B.E./B.Tech), Diploma in Medical Devices, Biomedical, Instrumentation, MSc/BSc in Respiratory Therapy, Critical Care, Paramedics, or Medical Devices. Prior knowledge or experience with ICU ventilators and Respiratory Devices would be preferred. Strong technical aptitude and the ability to understand and explain complex medical equipment are essential. Additionally, candidates should possess strong organizational and multitasking abilities, as well as analytical and problem-solving skills. Sincerity, honesty, and hardworking nature are qualities that we value in our team members.,

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2.0 - 6.0 years

0 Lacs

noida, uttar pradesh

On-site

As a Service Engineer specializing in PCB Repairs, you will be responsible for repairing and replacing faulty PCB components in medical devices using precision tools. Your primary duties will include installing, maintaining, and repairing medical devices, ensuring their proper functionality, diagnosing and fixing technical issues, and identifying faults in PCB components and circuits. You will be expected to take prompt corrective actions for breakdown calls within the specified time frame, respond promptly to service requests, and resolve technical issues in medical devices including Criticalcare and life-support systems. Additionally, you will be required to detect and resolve faults in PCBs, SMD components, and electrical circuits, and perform repairs on key components such as PCBs, SMD components, ICs, and resistors. To qualify for this role, you should hold a Diploma or Bachelor's degree in Electronics, Electrical, Biomedical Engineering, or a related field. You should have 2-3 years of experience in PCB repair within the medical device industry and possess proficiency in diagnosing and repairing PCBs, including SMD and through-hole components. This is a full-time position with a day shift schedule located in Delhi NCR. You will also be responsible for providing on-site and remote technical support to customers and collaborating with the team to troubleshoot complex issues and find innovative solutions to enhance device performance and reliability.,

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4.0 - 9.0 years

9 - 10 Lacs

Ahmedabad

Work from Office

Provides advanced technical support, including comprehensive troubleshooting and escalation support, ensuring accurate diagnostics and resolutions while strictly adhering to regulatory guidelines and safety protocols. Conducts in-depth diagnostics and repairs on complex medical devices, ensuring minimal downtime and optimal performance to meet the critical needs of healthcare providers and patients. Understands implications of work, makes recommendations for solutions, and utilizes experience and in-depth knowledge to complete a wide range of tasks in resourceful and effective ways. Exercises within established procedures, utilizes specialized skills to perform in-depth analysis of assigned tasks, identifying key issues and patterns and resolves moderately complex problems to drive results. Executes thorough pre-visit preparation, ensuring that all necessary parts, tools, and diagnostic information are available to achieve resolution in first visit and enhance customer satisfaction. Handles customer escalations and complaints by following established processes, ensuring accurate information capture, timely resolution, and maintaining high levels of customer service. Takes initiative with medium to high technical complexity support tasks, making informed decisions within defined frameworks to deliver effective solutions and improve device functionality. Engages actively in continuous improvement initiatives, sharing complex solutions and technical knowledge to enhance service quality, efficiency, and team performance. Provides technical mentorship and guidance to junior technicians, sharing expertise, best practices, and technical procedures to improve overall team capabilities and service outcomes. Collaborates with cross-functional teams and the wider organization to identify opportunities for sales or value-added services, supporting business goals and enhancing customer relationships. Minimum required Education: B.E. or B.Tech Minimum required Experience: Minimum 4 years of experience in IT, Network Diagnosis, System Connectivity, Remote Service within Engineering, Medical, Diagnostic Imaging service environment or Electromechanical Industries or Science related environment or equivalent. Preferred Education: Associate Degree in Biomedical/Electronics or related field or equivalent combination of education and experience; Preferred Experience: Minimum 4 years of experience in IGT/MRI/CT (Diagnostic Imaging) service environment or minimum 4 years of experience in Electromechanical industries. with OEM experience preferred, Preferred Skills: Troubleshooting Documentation & Reporting Continuous Improvement Product Installation Product Repair & Maintenance IT Networking Regulatory Requirements Engineering Fundamentals Remote Support Tools & Techniques

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1.0 - 4.0 years

3 - 6 Lacs

Mohali

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Sets up and operates haemodialysis machine to provide dialysis treatment for patients with kidney failure Attach dialyzer and tubing to machine and prime the extracorporeal circuits with 0.9% normal saline to prepare machine for use. Label dialyser & blood lines with patient name & ID prior to the first use (excluded single use). Preparing dialysis solutions and mixing bicarbonate according to formula Explains dialysis procedure and operation of haemodialysis machine to patient before treatment to allay anxieties. Connects haemodialysis machine to patient s access site to initiate dialysis. Monitor haemodialysis machine for malfunction. Maintain all the log books, forms & registers.

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8.0 - 13.0 years

8 - 12 Lacs

Hyderabad

Work from Office

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Lead, mentor and coach junior Quality and Validation engineers in their activities Analyze test results, collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, deviations, change control, non-conformance and other Computer System Validation (CSV) documents. Ensure validation strategies meet regulatory requirements and company standards. Guide junior validation engineers in writing the CSV documents and verify their output for completeness, accuracy and quality. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Lead test automation scripting, framework maintenance, and CI/CD integration. Develop and execute automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Involve actively in release planning and estimate test efforts. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Software Quality and GMP Validation . Must-Have Skills: Experience in Quality Assurance (QA) testing with at least 6 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Strong experience in manual and automated testing for complex applications, especially in the 3DEXPERIENCE platform. Experience in Computerized System Validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience executing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills.

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7.0 - 8.0 years

7 - 11 Lacs

Bengaluru

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Responsible for 3D model creation and drawing development of designs for new mechanical subsystems used in medical devices. Experience 7 to 8 Years Total; 2+ years in design Responsibilities Creation and processing of Standard components Creation of deformable Components including routing elements 3D Model creation and design assembly solutions Assembly arrangement management Produce detailed drawings utilizing GD&T and CAD Infrastructure engineering best practices. Produce accurate GD&T tolerance studies. Participates in the preparation of semi-complex sketches, design layouts, and other specifications. Support Engineering changes through the Siemens design change process (CRB). Support detailed engineering analysis of new and existing designs to verify robustness and design intent. Design of sheet metal, machined, cast, and injection molded parts as well as 3D assemblies. Participate in drafting and design reviews with a cross-functional team. Qualifications Bachelor of Science in Mechanical Engineering (or equivalent experience) Min 5 years of industry experience in product design, development, and manufacturing with technical background in mechanical assemblies that are related to motion control and structures. Must have proficiency in NX CAD design software. GD&T skills and the ability to perform tolerance stack-ups on complex assemblies. Familiar with BCT aClass and classification a plus Familiar with Check Mate, IMM and DFMPro FEA software experience a plus (self-Simulator) Strong written and oral communication skills Proficiency with ASME Y14.5 standards Model: Hybrid model with 3 days working in office and 2 days possibly remote

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1.0 - 5.0 years

4 - 7 Lacs

Gurugram

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Sales Support Advising local/regional sales team on Digital Solutions applicable for customers Providing pre-tender/pre-sales input to sales team potentially including site visits with sales team to customers Providing input to tenders/sales offerings tailored to requesting customer Determining required software/hardware configuration to ensure correct ordering of required articles Supporting to promote and sell the maintenance digital services with commercial partners Project Management Providing project management for implementation projects at customers including coordination with Support Engineering and Technical Operations teams Providing project management for complex migration projects (e.g. TMan to TSS, or future software migrations) Product pilot projects Leading project resources Independently handle correspondence with customers and subsidiaries Advising customer IT to ensure the customer IT infrastructure requirements fulfilled Providing detailed implementation project plan and discuss timing with local sales and/or customer Planning and organizing end user application training with responsible application trainer Project Execution Install and configure digital solutions on customer systems Ensuring full functionality by decent testing before taking digital solutions into production Follow-up on open topics after project closure Supporting customers after project implementation and incidents management. Support: 1st Level MedTech Remote Support for all Digital Solutions offered by the company Care of the ticket system Problem solving of incidents remotely or on site Collaborate with Application Specialist/Technical Operations in all MedTech/Digital Solutions matters Processing/coordination and forwarding of technical customer inquiries Provision of error diagnostics and fault containment Independently handle correspondence with customers and subsidiaries Compliance with SLAs Adjustments and configurations of the software, hardware and medical devices Business continuity: Installation, update, upgrade, patching and configuration of Digital Solutions in the markets Monitoring and following-up on open orders in the local organizations Technical elaboration and collaboration in the preparation of offers Coordination of suppliers with whom there is a dependency General function related: Provide input to the continuous improvement of processes Provide input to the improvement of support templates Active use of support tooling Collaborate with and support the DSO Project Hubs in case of resource shortage Proactive work planning: allocation and organization of own work plan Setting own as well as working on defined priorities according to priority matrix in order to meet productivity, efficiency, quality and time standards Follow all relevant FME policies, guidelines, manuals, and SOPs as updated from time to time Participation in relevant product certification training and update courses in FME. Provide technical insights from customer feedback, marketing dynamics and competitions. Documentation Complete documentation of the executed work in accordance with the Medical Device Regulation and Standard Operating Procedures (SOPs) in all required systems (e.g. ticketing system, system for medical device registration) Documentation of requests for change Assist in creation of documentation and instructions (e.g. project related, best practices) Maintaining and expanding the knowledge base Remote access management

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3.0 - 6.0 years

6 - 10 Lacs

Bengaluru

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Job Requirements Embedded Firmware Engineer, Domain - Medical Devices, Location - Bangalore Work Experience Must have hardware debugging skills for a Firmware developer. C and C++ programming Microcontrollers & Microprocessors programming Software optimizations skills at the System on a Chip (SoC) level Real-time Operating Systems (RTOS) Device drivers, including Linux Understanding of design patterns and embedded system design patterns Debugging skills Ability to work with existing codebases Interrupt-driven design Assembly programming language Hardware test equipment: oscilloscope, logic analyzer Experience in or ability to learn communication protocols. Relevant protocols to have at least an understanding of include I2C, Serial Peripheral Interface (SPI), USB, General-purpose input/output (GPIOs), Controller Area Network (CAN bus), CANOpen, Recommended Standard 232 (RS232), one-wire, Recommended Standard 485 (RS485) Ability to read a schematic, it must and excellent debugging skills. Basic understanding of Internet of Things (IoT) and internet-based technologies Understanding of data structures Python programming language RISC-V instruction set architecture Additional technical skills an embedded systems engineering should have include: Deep experience with both hardware and Firmware Understand design patterns and embedded system design patterns GNU Project debugger, including both local and remote debugging Design patterns Multiprocessor design Multi-subsystem issues Python programming language Open-source software Wireless connectivity, including Wi-Fi and Bluetooth low energy (BLE) Unified Modelling Language

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1.0 - 8.0 years

5 - 9 Lacs

Coimbatore

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Roles & Responsibilities : Were looking for an Embedded Linux Engineer specializing in Yocto-based system development for medical devices. This role focuses on building and maintaining custom Linux distributions. Key Responsibilities: Develop and maintain Yocto-based Linux systems Create and modify Linux device drivers Optimize boot time and system performance Implement secure boot and system updates Support BSP development and maintenance

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3.0 - 5.0 years

11 - 13 Lacs

Bengaluru

Work from Office

As a part of our dynamic team, you ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models. Responsibilities Plan, establish and maintain a Quality Management System in accordance with EN ISO 13485 Implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA and CE Marking, etc Prepares dossiers and device master files for regulatory submissions Follow the Medical Device Act by CDSCO and other relevant regulations related to products developed and provide directions for compliance to the organization. Work with different teams to setup Quality policies and standards Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards. Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations. Working closely with product development and product transfer teams Supplier Audit and Qualification. Assist with Management Review meetings including generation of quality metrics and coordinating the review. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal procedures to assure compliance for QMS. Lead audit and inspection preparation, resolution of audit and inspection findings with relevant stakeholders through all stages of the audits. Coordinate CAPAs meetings and provide assistance to the corrective action owners to ensure effectiveness. Ensure employee training compliance to Corporate and site-level QMS. May be responsible for preparing and facilitating quality related training programs for employees. Requirements Educational Qualification- B.Tech Minimum 3-5 years of experience in Medical Device Regulation. Experience with international medical device regulatory approvals and submissions Experience supporting regulatory agency inspections and Notified Body Audits in an SME role Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices as well as IEC 62304 Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents Proven experience in new medical device registrations and filings Working experience with CDSCO, Notified body and other associations for medical device regulation Able to constructively collaborate with cross-functional teams Working knowledge of quality assurance methodologies Knowledge of commonly-used concepts, practices, and procedures for a full product development life-cycle and Medical Device Quality Management System. Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained. Providing guidance to the team to interpret regulatory requirements for various life-cycle stages of the project Drive Good Documentation practices Ability to follow instructions, work independently, or function in a team as needed Highly organized, process orientated and adherence to standard process. Exhibit good leadership across departments and teams. Good time management and project management. Collaborative and a team player Good interpersonal, listening and communication skill

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1.0 - 3.0 years

3 - 5 Lacs

Madurai, Coimbatore

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Achieve sales targets & expand market share for IVD products. Develop and manage relationships with hospitals,diagnostic labs & channel partners Coordinate with application specialists & service teams Mointor market trends & provide strategic inputs.

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3.0 - 8.0 years

4 - 7 Lacs

Vijayawada, Visakhapatnam, Hyderabad

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Achieve sales targets & expand market share for IVD products. Develop and manage relationships with hospitals,diagnostic labs & channel partners Coordinate with application specialists & service teams Mointor market trends & provide strategic inputs.

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3.0 - 5.0 years

4 - 5 Lacs

Kolhapur, Nashik, Pune

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Achieve sales targets & expand market share for IVD products. Develop and manage relationships with hospitals,diagnostic labs & channel partners Coordinate with application specialists & service teams Mointor market trends & provide strategic inputs.

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3.0 - 8.0 years

4 - 7 Lacs

Bhopal, Indore, Raipur

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Achieve sales targets & expand market share for IVD products. Develop and manage relationships with hospitals,diagnostic labs & channel partners Coordinate with application specialists & service teams Mointor market trends & provide strategic inputs.

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5.0 - 19.0 years

0 Lacs

guntur, andhra pradesh

On-site

As a Sales Engineer at Ababil Healthcare Pvt Ltd, you will play a crucial role in selling ICU/OT products in your region. Reporting to the Sales Manager, you will have the opportunity to showcase your dynamic and goal-driven nature while building a successful career in the medical field. If you are someone with a network within hospitals and a drive to represent a top brand, this role offers a great platform to train and develop passionate sales professionals. Your key responsibilities will include differentiating Ababil products by effectively conveying their value propositions, developing and presenting solutions, and closing complex sales deals. By building relationships with departmental decision-makers and accessing C-Suite influences, you will be able to identify key accounts, generate new leads, and develop a regional growth strategy. To ensure success in this role, you will create and manage territory plans, including competitive strategies and target accounts, while utilizing CRM tools to track opportunities and manage the sales funnel. Furthermore, you will be expected to conduct product demonstrations, engage in clinical and commercial networking, and promote the brand at industry events. Providing training to team members, submitting regular activity reports, monitoring competitive activity, and representing Ababil in various capacities will also be part of your responsibilities. To excel in this role, you should have a proven track record of successfully selling medical devices to Corporate and Private Sector hospitals, along with a strong network of Key Opinion Leaders (KOLs) in your region. Your ability to work independently, coupled with excellent relationship-building and communication skills, will be essential. Proficiency in English and local languages, as well as computer and analytical skills, will further strengthen your candidacy. Ideally, you should have prior experience in medical sales, customer service, or a related field, along with a Bachelor's degree in a related discipline. Strong organizational, negotiation, and time-management skills are highly valued in this role. Ababil Healthcare Pvt Ltd, headquartered in Chennai, Tamil Nadu, India, is a company dedicated to enhancing healthcare by providing state-of-the-art medical equipment and integrated solutions to healthcare providers. With a commitment to growth and knowledge, the company aims to help people live healthier lives and improve the efficiency of the healthcare system. Ababil Healthcare's product portfolio focuses on critical care units such as Operation Theatres, Intensive Care Units, Cardiology, and Homecare. Ventilators, defibrillators, patient monitors, infusion pumps, ECG machines, anesthesia workstations, and respiratory care supplies are among the range of medical equipment and services offered by the company. In addition to supplying medical devices, Ababil Healthcare provides comprehensive services and support, including application training, maintenance, calibration, and warranty programs. By ensuring that healthcare professionals can effectively utilize their equipment, the company aims to enhance patient care and contribute to the overall efficiency of the healthcare system. With branches in Bangalore, Karnataka, and Hyderabad, Telangana, in addition to their headquarters in Chennai, Ababil Healthcare extends its reach to serve a broader clientele across India. Joining the team at Ababil Healthcare Pvt Ltd as a Sales Engineer presents an exciting opportunity to be part of a company committed to improving healthcare outcomes and making a positive impact in the medical devices industry.,

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5.0 - 9.0 years

0 Lacs

maharashtra

On-site

The Product Manager - Medical Devices is responsible for leading global sales efforts for the company's medical devices and equipment. In this role, you will serve as the technical expert and product champion, providing in-depth product knowledge and support to sales teams and clients. Your primary goal will be to ensure customer satisfaction through your technical expertise and market representation. As the Product Manager, your key responsibilities will include: - **Product Expertise**: You will act as the primary technical expert for the company's medical devices range, thoroughly understanding product specifications, features, and clinical applications. - **Sales Enablement**: Collaborate with sales teams to provide technical training, product knowledge, and sales strategies to boost performance in international markets. - **Market Representation**: Travel to key international markets to present products, conduct demonstrations, and engage with clients and distributors. - **Customer Support**: Assist clients with pre- and post-sales technical support, addressing product-related inquiries, troubleshooting issues, and ensuring smooth product implementation. - **Product Development Feedback**: Gather market insights and customer feedback to influence product improvements and new feature development in coordination with the R&D team. - **Market Expansion**: Identify and prioritize opportunities for expanding the product's reach into new markets, helping the sales team develop localized strategies for each region. - **Relationship Building**: Develop strong relationships with international clients, distributors, and key stakeholders to foster long-term business growth. Qualifications required for this role include: - 5+ years of experience in medical devices and equipment, with strong product management or technical sales experience. - Extensive knowledge of medical devices, with the ability to explain technical specifications and support sales teams and clients. - Excellent communication, problem-solving, and presentation skills. - Proven ability to work in international markets and travel frequently. - Strong market analysis and product development feedback skills. If you are interested in this position, please send your resume and cover letter to info@globalsouthhealth.com.,

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3.0 - 8.0 years

0 - 0 Lacs

Hyderabad, Bengaluru

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Role & responsibilities Cold call and visit prospects on location Set appointments with hospital staff and administrators Manage all leads and customers within a defined territory Build relationships with hospital staff Educate medical staff on the benefits of medical devices Provide product demonstrations and support Place replenishment orders at existing accounts Maximize profits by upselling and cross selling additional products Communicate between sales, marketing, and support teams to improve customer experience Collect, analyze, and present field sales data to assists with strategy planning and implementation. Manage and Support the Sales Team to drive Medical Products sales for profitable growth as per the assigned targets Handling team of people to achieve the targets of individuals and branch. To prepare accurate market and business forecast. To work as per guidelines and protocol of the serving organization. Developing/Conducting onsite training sessions for team channel partners and customer Market mapping of assigned territory and to qualify and convert leads to orders from the market map data. Review competitors activities in the market To work closely with key accounts, major institutes and medical colleges Preferred candidate profile To take a final call on the pricing section to close the deal with the client. Providing Training to the new Sales joinees. Sales forecast report preparation. Independently handle technical, sales and financial discussions

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8.0 - 12.0 years

16 - 31 Lacs

Pune

Work from Office

Analyze system requirements, user needs and system design, perform system evaluation activities (i.e. validation, verification). Transform requirements into comprehensive test protocols and automated test scripts using Python. Develop and maintain high quality non-medical device software tools in a regulated environment to support system design and system evaluation activities. Documents software development and/or test development by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving System level issues. Interact with business analysts, SMEs and QA team members Qualification & Required Skills Bachelors degree in engineering or equivalent (BE, B Tech, MCA, MSc) 8+ years of product testing experience, preferred to have experience in system testing with devices and simulators.• Experience in regulated product development environment, particularly for medical devices, a plus.

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2.0 - 5.0 years

3 - 4 Lacs

Faridabad

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Urgent Requirement of Biomedical Engineer@ Amrita Hospital Faridabad Exp - 2 to 5yr Qualification - BTech (Biomedical) Salary - As per industry norms Interested Candidates Can Contact - Rahul Chauhan - 9911892435 Email ID - rahul.chauhan@fbd.amrita.edu

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2.0 - 5.0 years

3 - 4 Lacs

Ghaziabad

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Urgent Requirement of Biomedical Engineer@ Amrita Hospital Faridabad Exp - 2 to 5yr Qualification - BTech (Biomedical) Salary - As per industry norms Interested Candidates Can Contact - Rahul Chauhan - 9911892435 Email ID - rahul.chauhan@fbd.amrita.edu

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2.0 - 5.0 years

3 - 4 Lacs

Greater Noida

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Urgent Requirement of Biomedical Engineer@ Amrita Hospital Faridabad Exp - 2 to 5yr Qualification - BTech (Biomedical) Salary - As per industry norms Interested Candidates Can Contact - Rahul Chauhan - 9911892435 Email ID - rahul.chauhan@fbd.amrita.edu

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2.0 - 5.0 years

3 - 4 Lacs

Noida

Work from Office

Urgent Requirement of Biomedical Engineer@ Amrita Hospital Faridabad Exp - 2 to 5yr Qualification - BTech (Biomedical) Salary - As per industry norms Interested Candidates Can Contact - Rahul Chauhan - 9911892435 Email ID - rahul.chauhan@fbd.amrita.edu

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