Baxter India Pvt Ltd

The role of Senior Engineer Systems& MBD is to contribute to design and development of a product or solution, from conception to design and verification/validation. You will apply expert technical knowledge and engineering principles in the development of products and solutions. You will help accelerate the design and development cycle by employing model based design principles and developing MATLAB models working together with the hardware and software teams. You will collaborate with cross functional team for technical issues, design changes, design reviews, and complex problem resolution. This position is based out of Bangalore and reporting to the Manager Systems and V&V for Patient Support Systems and Global Surgical Solutions divisions. Essential Duties and Responsibilities : Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, Design trade-offs and Risk assessment early in the development cycle working independently or under the guidance of senior staff. Use MATLAB to develop Model Based Design working together with hardware and software teams and help accelerate product development cycle. Provide your technical expertise to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle. Excels in the development of Use Case for product or solution based on intimate knowledge of customers and their environments. Use industry standard tools and excel spreadsheets in the management of requirements and decomposition of system level requirements to modules. Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety. Identify development issues and facilitates in the resolution using optimal technology solutions. Supports in the Usability Engineering activities to ensure the application of human factor in the development of products or solutions to demonstrate compliance to IEC 62366 and FDA guidance. Knowledge in the application of principles of Reliability and Robustness in the development of products or solution. Completes detailed, high quality technical documentation to capture and communicate designs. Support integration issues during development tests and ensure module / system development is successful. Actively collaborate with software and hardware engineers to aid in the design development. Actively engage with verification and validation engineers to aid in the development of verification test plans with good test coverage. Your Team: This position will be reporting to the Manager Systems and V&V for Patient Support Systems and Global Surgical Solutions divisions. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions. Your Location: The role is in Baxter R&D facility in Bangalore India. What You'll Bring: Bachelor's Degree with 6+ years or Masters with 3+years experience in Bio-medical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Mechanical Engineering, Industrial Engineering or related field Experience in System engineering function of Medical device/ Medical Imaging / Image processing, with hands on experience developing MATLAB system models. Experience in Medical Device development, FDA Regulations and MDR. Exposure to Usability Engineering Process Experience in QFD, Pugh Matrix, CTQ, DFR, DFX Strong interpersonal skills with the ability to collaborate with others in a team environment

Job Description The role of Engineer II, Systems is to contribute in design and development of a product or solution, from conception to design and verification/validation. You will apply expert technical knowledge and engineering principles in the development of products and solutions. You will help accelerate the design and development cycle by employing model based design principles and developing MATLAB models working together with the hardware and software teams. You will collaborate with cross functional team for technical issues, design changes, design reviews, and complex problem resolution. This position is based out of Bangalore and reporting to the Manager Systems Engineering for Patient Support Systems and Global Surgical Solutions divisions. Essential Duties and Responsibilities : Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, Design trade-offs and Risk assessment early in the development cycle working independently or under the guidance of senior staff. Use MATLAB to develop Model Based Design working together with hardware and software teams, and help accelerate product development cycle. Provide your technical expertise to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle. Excels in the development of Use Case for product or solution based on intimate knowledge of customers and their environments. Use industry standard tools and excel spreadsheets in the management of requirements and decomposition of system level requirements to modules. Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety. Identify development issues and facilitates in the resolution using optimal technology solutions. Supports in the Usability Engineering activities to ensure the application of human factor in the development of products or solutions to demonstrate compliance to IEC 62366 and FDA guidance. Knowledge in the application of principles of Reliability and Robustness in the development of products or solution. Completes detailed, high quality technical documentation to capture and communicate designs. Support integration issues during development tests and ensure module / system development is successful. Actively collaborate with software and hardware engineers to aid in the design development. Actively engage with verification and validation engineers to aid in the development of verification test plans with good test coverage. Your Team: This position will be reporting to the Manager Systems Engineering for Patient Support Systems and Global Surgical Solutions divisions. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions. Your Location: The role is in Baxter R&D facility in Bangalore India. What You'll Bring: Bachelor's Degree with 6+ years or Masters with 3+years experience in Bio-medical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Mechanical Engineering, Industrial Engineering or related field Experience in System engineering function of Medical device/ Medical Imaging / Image processing, with hands on experience developing MATLAB system models. Experience in Medical Device development, FDA Regulations and MDR. Exposure to Usability Engineering Process Experience in QFD, Pugh Matrix, CTQ, DFR, DFX Strong interpersonal skills with the ability to collaborate with others in a team environment Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards. Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously Self-motivated with good interpersonal skills

The role of Principal Software Engineer , Product Security works in close collaboration with the project & cybersecurity Global lead on work you're doing and provides inputs to the design and testing of the new product/project. The engineer also provides mentoring and guidance to software developers on their security issues, engages in design reviews, and helps resolve security issues. This position is based out of Bangalore and reporting to the Software Manager for Patient Support Systems (PSS). What you'll be doing ! Responsible for the architecture and design of a module, makes architecture and design choices for new product development, sustenance activities, field issue resolution etc. Generates alternatives and takes reasonable risks while solving technical problems. Reviews and approves the design of a module. Demonstrates customer focus by ensuring quality of software releases and timely resolution of field reported issues. Identifies key module/product level technical risks and assists project lead in developing mitigation and recovery plan. Review work products and ensure high-quality output Provides recommendations to the test strategies at a product level Provides mentorship to development and test teams with respect to overall design & development. Leads and mentors the team members. Drives the application of principles of SDLC and methodologies like Lean/Agile/XP, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and testing techniques. Owns and drives continuous improvement activities by identifying and bringing up process and product quality gaps. Work and collaborate closely with Project team to define and tackle engineering changes/problems to make products that meet all performance and functional criteria within required project schedule, with minimum mentorship. Lead in design/change reviews with the Sustaining Team and Engineering Change Board justify design detail and collaborate with other team members Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed. Works on strategy and implements process to perform threat modeling, security risk assessments, vulnerability scanning, and penetration testing on various medical products and projects. Offer/Incorporate security mentorship and standard methodologies in the design and development lifecycle of various medical products. Your Team: This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions. Your Location: The role is located in the BRD facility in Bangalore India. What You'll Bring ! Bachelor's Degree or equivalent experience in Computer/Electronics Engineering, Computer Science with 9 to 15 years of work experience in SW development. 6+ years of security engineering experience Experience is preferred in/with vulnerability scanning, static code analysis, threat modeling , security risk assessments , penetration testing , cloud security (Azure), web application security, mobile device security. Strong Interpersonal skills with the ability to work collaboratively with others in a team environment Experience in the medical device industry and FDA Regulations is preferred Strong debugging/problem-solving skills. Thirst to constantly learn about new technologies and ways to improve. Strong interpersonal skills with the ability to work collaboratively with others in a team environment. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

For us, working at Baxter is not just a jobit's a calling. Our mission to save and sustain lives unites us. We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers. We're grateful you're interested in continuing your career journey with Baxter. This is where your purpose accelerates our mission and make a positive impact on millions of people around the world. JOB SUMMARY: A Systems engineering professional with experience in Systems areas like Product Requirements, management, Traceability, DHF structure & maintenance, Product Risk management, System integration, and Verification & Validation of medical devices. This position own & perform relevant Systems activities for a family of products for both PSS & GSS. The role of Principal Engineer Systems& MBD is to contribute in design and development of a product or solution, from conception to design and verification/validation. You will apply expert technical knowledge and engineering principles in the development of products and solutions. You will help accelerate the design and development cycle by employing model based design principles and developing MATLAB models working together with the hardware and software teams. You will collaborate with cross functional team for technical issues, design changes, design reviews, and complex problem resolution. This position is based out of Bangalore and reporting to the Manager Systems, Patient Support Systems and Global Surgical Solutions divisions. Essential Duties and Responsibilities : Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, Design trade-offs and Risk assessment early in the development cycle working independently or under the guidance of senior staff. Use MATLAB to develop Model Based Design working together with hardware and software teams and help accelerate product development cycle. Provide your technical expertise to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle. Excels in the development of Use Case for product or solution based on intimate knowledge of customers and their environments. Use industry standard tools and excel spreadsheets in the management of requirements and decomposition of system level requirements to modules. Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety. Identify development issues and facilitates in the resolution using optimal technology solutions. Supports in the Usability Engineering activities to ensure the application of human factor in the development of products or solutions to demonstrate compliance to IEC 62366 and FDA guidance. Knowledge in the application of principles of Reliability and Robustness in the development of products or solution. Completes detailed, high quality technical documentation to capture and communicate designs. Support integration issues during development tests and ensure module / system development is successful. Actively collaborate with software and hardware engineers to aid in the design development. Actively engage with verification and validation engineers to aid in the development of verification test plans with good test coverage. Involved from new product development to post market surveillance at various stages of product lifecycle. Primary point of contact for R&D for PMO & cross-functional team for integration, execution, project deliverables, budget & resource needs. Your Team: This position will be reporting to the Manager Systems, Patient Support Systems and Global Surgical Solutions divisions. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions. Your Location: The role is in Baxter R&D facility in Bangalore India. What You'll Bring: Bachelor's Degree with 12+ years or Masters with 8+years experience in Bio-medical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Mechanical Engineering, Industrial Engineering or related field Experience in System engineering function of Medical device/ Medical Imaging / Image processing, with hands on experience developing MATLAB system models. Experience in Medical Device development, FDA Regulations and MDR. Exposure to Usability Engineering Process Experience in QFD, Pugh Matrix, CTQ, DFR, DFX Strong interpersonal skills with the ability to collaborate with others in a team environment Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards. Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously Self-motivated with good interpersonal skills Able to deliver on multiple projects simultaneously Ability to identify compliance risks and escalate, when necessary, Excellent verbal and written English communication skills, suitable for multi-location working relationships, Demonstrated teamwork and collaboration skills, Aptitude for Mindfulness and attention to detail,

To maintain compliance with local needs and global requirements as per defined procedures. To receive market complaint & share with cross-functional teams (CFT), keep tracking of all received complaints and share status of complaint to concerned cross-functional teams. To perform & assist the complaint investigation, root cause analysis and its mitigation and associated Corrective and Preventive Action (CAPA), along with CFT members within specified timelines. To prepare the investigation report and send to respective CFT members for review/approval. To carry Field Alert Report (FAR) or Quality Defect Report assessment for each received Market complaint, OOS and NCR (if applicable). To carry risk analysis of received complaint as mentioned in local procedure. To close the complaint evaluation in Complaint Management System (Trackwise 8) within specified timelines & as per local and global requirement. To Initiate & handle Document Change Request (DCR), Non-Conformity Report (NCR) or Corrective and Preventive Action (CAPA) as per defined procedure. To be a part of all internal and external audits and inspections. To prepare Field Alert Form and Quality Defect report for regulatory submission and communicate with MAH/QP/Country Manager, as applicable for regulatory notification. To initiate and handle Field Actions (Product/Mock Recall) & related activities in Field Action System (FAS) as specified in local & global procedures. To initiate and handle Corporate Hold & related activities in Baxter Hold System (BHS) as per defined local & global procedures. To prepare and revise Standard Operating Procedures in TcU and perform its Gap Assessment with respect to Global Procedure in timely manner. To Maintain, Archive & Destruct the documents associated with Market Complaint, Field Action (product/mock recall), Field Alert Report/Quality Defect Report, Product Hold as per defined procedure. To fetch details from Quality Portal in timely manner (as per SOP) & prepare Quality Metrics/Trend Report associated Market Complaints/Field actions/Product Hold/FAR & QDR and share Market Complaint Manager &/or with CFT (as applicable) for review/approval.

Supports regulatory project plan execution Maintain awareness of regulatory requirements and ensure continued learning Maintain regulatory files in a format consistent with requirements Participate as an active team member of project teams as required Compile and prepare responses to questions from regulatory authorities according to plan Edit and proofread regulatory documentation Assist in preparation and review of labeling, SOP's, and other departmental documents Compile under supervision regulatory documents for submission Track status and progress of regulatory documentation Understand Regulatory Affairs position in small project teams

Ensure the implementation and maintenance of Quality Management System elements at the site. Achieve compliance with global quality metrics and submit quality metrics data to the QA Head and management on time. Track and implement improvement objectives identified during quality metrics presentations. Evaluate departmental efficiency and ensure required training for cross-functional team members is provided. Assist the QA Head in implementing Electronic Quality Management System (E-QMS) modules to handle QMS elements effectively across the plants. Ensure non-conformities (NCR/SNCRs) are adequately investigated, root causes identified, and effective Corrective and Preventive Actions (CAPA) are implemented. Review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions. Ensure Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR) are adequately investigated. Review and approve Change Control Management (CCM) and Document Change Requests (DCR) as per Standard Operating Procedures. Monitor and ensure key performance indicators are maintained periodically and achieved. Ensure data reliability is in place. Conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time. Attend CAPA review board meetings and monthly quality metrics review meetings on time. Support external and internal audits at the site, providing observations related to QMS compliance. Communicate cross-functional requirements to concerned personnel and functions. Maintain and monitor the functional budget periodically. Support quality functions as required by the business. Inform key management teammates about critical quality-impacting QMS elements and raise concerns about potential deviations that could affect quality metrics.

Develops high-quality, reliable, and efficient hardware designs for medical devices, including analog, digital, and mixed-signal circuits. Collaborates with cross-functional teams to ensure successful integration of designs into medical products. Participates in the development of new products, from concept to production. Ensures successful integration of electrical design with mechanical and software elements of the system. Provides technical guidance and mentorship to junior engineers. Develops, modifies, and approves electrical design documentation, specifications, and drawings. Supervises/coordinates an engineer and/or technicians on assigned work. Defines design requirements and hardware specifications based on customer or user requirements. Contributes to the development and documentation of electronic system architectures. Conducts design reviews, trade-off analyses, and risk assessments to ensure the optimal design solution is selected for each project. Leads the creation of designs of analog and digital electronic circuit schematics for microcontroller-based systems, meeting performance objectives. Analyzes circuits using calculation and simulation methods to assess performance limits, effects of environmental and load stress, and timing interfaces to ensure consistent performance in safety-critical applications. Stays up to date with industry trends, emerging technologies, and regulatory requirements to maintain a competitive edge. Contributes to the development of design verification and validation plans, as well as executing tests to ensure design compliance with specifications. Defines appropriate test methods to verify designs meet their performance requirements. Completes deliverables related to design of systems and sub-systems of the overall electrical architecture. Collaborate with suppliers and external partners to source components and ensure component reliability and availability. Participates in the transfer of design knowledge and intellectual property to manufacturing teams to ensure successful production ramp-up. Contributes to the continuous improvement of design processes, tools, and methodologies to improve efficiency and quality. Directs the layout of circuit assemblies to meet emissions and immunity performance requirements and design for manufacturability guidelines. Executes protocols and testing required to validate the safety and effectiveness of the design(s). Leads the troubleshooting and problem-solving efforts related to electrical aspects of devices and associated systems. Creates and communicates design/test plans, tasks, deliverables, and status. Manages time and resources to meet committed schedule milestones.) Qualifications A Bachelor's or Master's degree in Electrical or Electronics Engineering or a related field is required, with a minimum of 11 years of experience in electro-mechanical medical device product design. Knowledge of infusion pumps medical devices is an added advantage. Strong foundation in electrical engineering principles, including analog circuits, signal processing, and power electronics. Proficiency in circuit design, analysis, and simulation using tools such as SPICE, Matlab, and AWR Design Environment. Strong knowledge of analog components, such as transistors (BJTs and FETs), Operational amplifiers (op-amps), Filters (low-pass, high-pass, band-pass, etc.), Sensors (temperature, pressure, acceleration, etc.), data converters (ADCs, DACs), sensors (temperature, pressure, acceleration, etc.) Familiarity with PCB layout and design for manufacturability (DFM) principles. Knowledge and experience using CAD systems for printed circuit board schematic design and layout (Altium Designer, preferred). Understanding signal integrity and power integrity concepts to ensure reliable performance of analog circuits. Experience with measurement and testing equipment to verify circuit performance. Experience with design automation tools, such as LabVIEW, Cadence Virtuoso, AWR Design Environment, or MATLAB. Strong problem-solving skills and the ability to work independently and collaboratively. Excellent communication skills, both written and verbal, with the ability to effectively communicate complex technical concepts to non-technical stakeholders. Strong organizational skills and the ability to manage multiple projects simultaneously. Experience with regulatory requirements, such as FDA 510(k) and IEC 60601, is a plus. Familiarity with agile development methodologies and ability to work in a fast-paced, dynamic environment and adapt to changing priorities.

To take instructions from Supervisor and shift lead to perform the shift activity. To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records. To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR. To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place. To collect In-process samples, finished product samples, and other samples timely submission into QC/micro. To review and verification of electronic records/Audit trails and printout of the equipment's like autoclave, sterilizer, filter integrity machine and any other equipment's etc. To ensure the respective documents to be destructed as per approved procedure. To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured. To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification. To execute the approved Corrective and Preventive Action (CAPA) with in define timeline. To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure. To prepare and review the SOPs. To carry out stagewise BMR review for batch execution compliance. To track the CPV Program through provided exhibits and to prepare the Minitab files for required products based on production plan for the month. To collect the data related to CPPs/ CQAs and shall perform data analysisy. Report any abnormality gap to supervisor /Shift lead. To maintain the admin logins for all applicable equipments and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users. Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required. To approve the preventive maintenance activities in MAXIMO and risk assessment review and approval. To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook. To communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution. To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review. Material A.R.No. Stock Blockage or Un-blockage in System. To perform the periodic building inspection with Admin team. Any other responsibility assigned by shift lead and reporting manager.

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification. To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Supervisor regarding any non-conformity from planning and execution. To prepare monthly and annual calendars for various periodicqualification/validations& get it reviewed by Supervisor and approved by Manager. To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Trackwise. To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date. To ensure samples withdrawal during process validation & keep Supervisor updated about any non-conformity. To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents. To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by Supervisor. To attend trainings of each protocol before execution of any validation and qualification activity. To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA. To update the protocols as per current regulatory requirement to improve the validation documents. To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Supervisor for review & approve. To keep the validation document updated from GMP aspect as per regulatory expectation. Planning and execution of validation activities associated with QMS elements. To inform the activity or issues which might occurred during the shifts validation activities through daily meeting.

Planning Monthly account wise planning of secondary sales leading to primary sales for their territory/accounts Weekly planning for coverage and calls Monthly/quarterly sales forecast for defined territory Quarterly activation planning Execution Drives adherence to SFE processes :, Call average, customer coverage, working days, SME trackers, prescription tracker, secondary sales and product sampling/demonstrations To track all product and service quality related complaints and coordinate with National/Sales Manager/quality to ensure formal response and closure to complaints report it to PV & Quality Competition & Market Mapping -- Track and gather market data, no. of indicated surgeries, gather and analyze competitor activities P5 Implementation Implementation of Marketing strategy and activations as per defined GTM Identify and drive business development initiatives in his/her current /new accounts including training and education of paramedical staff Ensure speedy and adequate availability of products in his/her accounts Financial Achievement of monthly secondary sales target revenue numbers (SFE) Non Financial Alignment to P5 plan (Segmentation and Targeting) Deviation from MCL and account plan (WIP) SME development As per defined list (WIP) Market Activations as per GTM (SFE) Behavioral Drive for results Persuasive Communication Data analysis and Problem solving skills Market Orientation Planning and Prioritization People Management Functional: Consultative Selling skills Product/Therapy/Competitor knowledge Strategic key account management Negotiation skills Work with marketing to drive execution of campaigns and activations Govt. and Corporate account sales target Territory Performance Account planning & performance Activation Plan Subject Matter Expert (SME) Management at account level Pricing decisions at account level through competition mapping Mission Critical Collaborators: Sales Manager Marketing BaxSol and Corp Account Sales Team

Identifiestechnical problems, provides innovative, creativesolutionsand shares technical knowledge with team. Incorporates business, market,industryand competitive knowledge into technical solutions that can be readily adapted to changes in technology and/or clinical use. Generates alternatives and takes reasonable risks while solving technical problems. Reviews and approves the design of a module/project Demonstrates customer focus by ensuring quality of software releases andtimelyresolution of field reported issues Responsible for analyzing and understanding the requirements. Review work products and ensure the quality of deliverables Provides input to the test strategies at a product level Provides guidance to development and test teams with respect to overall design and development. Demonstratesthe application of principles of SDLC and methodologies like Lean/Agile/XP, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and testing techniques. Owns and drives continuous improvement activities byidentifyingand appropriately escalating process and product quality gaps. Work and collaborate closely with Project Manager to define and solve engineering changes/problems to make products that meet all performance and functional criteria within required project schedule, with minimum guidance. Participatein design/change reviews with the Sustaining Team and Engineering Change Board justify design detail and collaborate with other team members Challenges project teams and established work processes and proactively finds creative methods to reach desired performance levels Collaborate with internal and/or external parties in the development, improvement, andmaintenanceproducts. Identifyand report any quality or compliance concerns and take immediate corrective / Preventive action as needed. What you'll bring Bachelor's Degree in Computer Science/Electronics Engineering, Computer Sciencewith6to9yearsofworkexperience inembedded SW development. Experience in complete embedded software development life cycle from concept to release. Experience in CommunicationProtocols:(CAN/Can-Open, I2C, Bluetooth, UART, SPI, USB, TCP/IPetc). Experience with Microcontroller's like STM32 family, TIVAseries,i.MX series. Experience in RTOS (Micrium/FreeRTOS/embOS/COSetc).OS scripting and internals. Experience in Debuggingtoollike (Oscilloscope/CAN Analyzer/Peak Analyzer/IC5000/J-Linketc). Experience with Development Environment and toolchain(KEIL/STM32Cube/TIVA/Code Composer Studio). Experience in Programming Languages like Embedded C, C++ etc. Experience with Bare Metal Architecture and Device Drivers is a plus. Expertisein development and maintenance of Software embedded/distributed systems Strong Object-Oriented development and design knowledge and experience Knowledge of IoT, Cloud development and Cybersecurity technology will be an advantage. Deep understanding of technology & software development principles. Analysis and Design: ObjectOrientedArchitecture, Design Patterns. Experience inDevelopment and Continuous Integration tools like Visual Studio/Eclipse, SVN, Git, Gerrit, Jenkins,Bitbucket, Jira etc. Experience inCode Quality tools like Coverity, Fortify, Unit test tools. Demonstrated success in delivering results on technical challenges. Good understanding ofhealthcaredomain (regulations and standards) andmedicalsoftware development process. Excellent communication, inter-personal and leadership skills Firm decision maker and shallpossessgood influencing skills Openness to collaborate in interest of project/organization. Proactive and self-driven,possessesdue sense of urgency Shallpossesssystems mindset and good problem-solving abilities. Working with multisite teams, Quality conscious and Process & customer Oriented Coaching capabilities. Self-motivated with good interpersonal skills

Strategizing and planning Verification activities independently/along with other leads Verification and validation of Software as a system using manual and automated test methods. Creation and execution of Verification and Validation plans, including coordinating efforts of test personnel inside and outside the Design Verification and Validation group. Reviewing test procedures, test input documents and test results Defining test setups and environment required for test execution Driving Challenging verification, sampling strategy & Non-functional req. tests Documenting any design defects (product non-conformances) discovered. Interfacing with other engineering disciplines to research, correct, and close design defects. Publishing test reports, defect summary report, performing defect analysis, driving defects to closure Managing traceability from requirements to verification Ensuring that the testing abides by the business Engineering Quality Procedures (QMS), Phased Review Discipline and regulatory needs of the applicable markets Development, implementation, and documentation of verification techniques. Participation in project meetings, project reviews, and specification reviews, Sprint Planning, Release Planning, Daily Scrums Development of new test systems and tools and maintenance of existing test systems Identifying and reporting any quality or compliance concerns and taking immediate corrective actions as required Interacting with global teams to promote consistency and maximize synergy Communicating effectively & impactfully in a cross-functional, multi-cultural, global environment Participating in and driving SW FMEA, dFMEA, FTA to define Risk Based Test Strategy Demonstrating Good structured approach for DSM, DBT Leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives What you'll bring Bachelor's or master's degree in engineering/science or equivalent At least 10+ years of experience out of which at least 2 years of experience as a Verification Lead at system-level for products that include Hardware and Software. Good knowledge of testing methodologies and processes, including manual, automated, standards and compliance testing Demonstrated skills for planning and coordinating verification and validation activities for New Product Development programs at a sub-system level. Demonstrated abilities and skills in working, influencing and communicating in a diverse global environment Demonstrated problem-solving and leadership skills Strong influential and communication skills Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971 Desired Characteristic Experience of having led verification for large and complex programs that includes stringent regulatory requirements and demonstrated automation implementation experience Advanced ISTQB Certification An engineer with Black BELT certification will be added advantage

Planning Monthly account wise planning of secondarysales leading to primary sales for their territory/accounts Weekly planning for coverage and calls Monthly/quarterly sales forecast for defined territory Quarterly activation planning Execution Drives adherence to SFE processes :, Call average, customer coverage, working days, SME trackers, prescription tracker, secondary salesand product sampling/demonstrations To track all product and service quality related complaints and coordinate with National/Sales Manager/quality to ensure formal response and closure to complaints report it to PV & Quality Competition & Market Mapping -- Track and gather market data, no. of indicated surgeries, gather and analyze competitor activities P5 Implementation Implementation of Marketing strategy and activations as per defined GTM Identify and drive businessdevelopment initiatives in his/hercurrent /new accounts including training and education of paramedical staff Ensure speedyand adequate availability of products in his/her accounts Financial Achievement of monthly secondary sales target revenue numbers (SFE) Non Financial Alignment to P5 plan (Segmentation and Targeting) Deviation from MCL and account plan (WIP) SME development As per defined list (WIP) Market Activations as per GTM(SFE) Behavioral Drive for results Persuasive Communication Data analysis and Problem solving skills Market Orientation Planning and Prioritization People Management Functional: Consultative Selling skills Product/Therapy/Competitor knowledge Strategic key account management Negotiation skills Work with marketing to drive execution of campaigns and activations Govt. and Corporate account sales target Territory Performance Account planning & performance Activation Plan Subject Matter Expert (SME) Management at account level Pricing decisions at account level through competition mapping Mission Critical Collaborators: Sales Manager Marketing BaxSol and Corp Account Sales Team

Review,Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device: Which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Installation/Operational/Performance Qualification Protocols, Traceability Matrices and Final Reports. Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables. Clear understanding of the elements of Risk Management, FMEA, critical / Essential parts identification, System reliability, Life / limits testing and related V&V tasks. Participate in the development of Verification & Validation methodologiesin accordance withapplicable Quality/Regulatory requirements and industry bestpractices Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures,calibrationand data collection. Diagnose,isolateand investigate problem reports. Drive product improvements and/or bug fixes. Ensure good documentation and Good Manufacturing practices are followed in the Verification and Validation Process Participate in continuous improvement activities by supporting the implementation of process and product quality improvementinitiatives Deep knowledge in test automation tools and realizing test automation suite. Work closely with the auditees to understand the details and support with all relevant objectiveevidences Adheres to Baxter Quality Management system & supportsthe qualityaudits. Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations. Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage.Identifyissues early to fixthe same. Refine the test plans and procedures through pre-verifications / Dry runs. Interacts with design team to resolve tests-related technical issues. Presents the findings / objectiveevidencesand able to present with rationale with applicability / exclusions Identifyand report any quality or compliance concerns and take immediate corrective / Preventive action as needed. What you'llbring Bachelor's degree in Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field 6to 10yrsof experience in Verification and validation testing ofSoftware andhardware. Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing. Understanding of hardware schematic diagrams and debugging tools like IC5000, CAN Analyzer,Trace 32, Keil IDE, PEAK analyzer, Oscilloscope Any scripting knowledge like python, shell etc. Good programming knowledge and basic understanding of Embedded programming. Understanding of modeling( MATLAB, Simulinketc) Test framework development and test harness development knowledge. Knowledgeonhardware in loop and software in loop testing. An understanding of test methods and processes as well as the methods used to verifyproductin the realmsof;software, mechanical, electrical, functional and environmental testing environments. Experience in - writing system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test reportgeneration Understanding of hardware and software product design methodologies and test practices. Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability. Experience in medical device or similar product development, design verification/validation,softwareintegration (involving software & hardware), risk management, reliability engineering, process validation and Qualitysystems Deep domain knowledge in design verification and validation of medical devices is aplus Understanding of and adherence to FDA, ISO and IEC design control procedures,regulationsand standards. Demonstrated experience in accomplishingobjectives. Able to deliver on multiple projectssimultaneously Self-motivated with good interpersonal skills

To monitor ongoing QMS event based training triggered through Non Conformance, CAPA, Market Complaints, SOP revisions etc. and ensure Effectiveness of the same. To facilitate new employee orientation at site and timely completion of required training for the assigned roles. Management of Learning Management System (LMS) and associated activities of course/ quiz, curriculum, assignments, history credit. Maintenanceof LMS system by timely revision of curriculum, credit of offline training, troubleshootingetc. To liaise with Corporate/ Global Teams for remediation and integration of Training systems in line with Baxter Global standards. To handle employee On Boarding and execution of Orientation program. To Execute training on Good Manufacturing Practices, Data Integrity Training, Trainer Qualification, any other training by Baxter Global / Third party / Consultants. To develop Content for the topics based on Annual Training Calendar, Campaign, Quality related etc considering site requirements/ necessities. Timely execution and completion of the topics driven through Annual Training calendar To measure the Effectiveness check of the training by On Job Training, Surveys, Feedback, Audits etc and to Align the effectiveness check in line with Baxter Global. To track and ensure timely completion of training. To assist Quality Culture through campaign based programs, initiatives, training programs, employee engagement/ sensitization programs. To assess Human Errors, Documentation Errors or any associated factors with respect to Training or Human element. Trend the data and define control measures to avoid re occurrence To track and monitor contingent workers training process and oversee qualifications, as required.

Strategic Imperative: Work Closely with the target surgeons ( Neuro-Surgery, CTVS, Plastic and GS ) & drive following strategic imperatives Awareness:Professionals understandwhichhigh-end H/S product to usewhen. Consideration: Professionals choose Baxter's high-end hemostat earlier instead of persisting with low-end Preference:Professionals utilize Baxter sealants more often at close. Planning Monthly account wise planning of secondary sales leading to primary sales for their territory/accounts Weekly planning for coverage and calls Monthly/quarterly sales forecast for defined territory Quarterly activation planning Execution Drives adherence to SFE processes :, Call average, customer coverage, working days, SME trackers, prescription tracker, secondary sales and product sampling/demonstrations To track all product and service quality related complaints and coordinate with National/Sales Manager/quality to ensure formal response and closure to complaints report it to PV & Quality Competition & Market Mapping -- Track and gather market data, no. of indicated surgeries, gather and analyze competitor activities P5 Implementation Implementation of Marketing strategy and activations as per defined GTM Identify and drive business development initiatives in his/her current /new accounts including training and education of paramedical staff Ensure speedy and adequate availability of products in his/her accounts

Having Hands on experience in designing and development of e-commerce applications usingSAP Commerce Cloud(Hybris). Possess Extensive Experience working with Spring Frameworks including Spring Core, Spring MVC,Spring Security and Spring Integration. Experience developing hybris web-based, e-commerce applications in a project-based environment. Extensive experience withSpring modules like IoC, Web, MVC, ORM, AOP, Spring Annotation Experience with HTML, CSS, and JavaScriptin an eCommerce setting. Knowledgeable in using frameworks such as jQuery. Possess In-depth experience in Full Life Cycle Implementations, Re- implementation and Post Implementation Support of Hybris application. Expert in SAP Commerce Cloud (Hybris) foundational concepts, data modeling with SAP Commerce Cloud (Hybris) and integrations. Excellent knowledge in SAP Commerce Cloud (Hybris) core concepts and commerce concepts, development of extensions and add-ons. Possess Extensive Experience working with Data Hub and ImpEx scripts to integrate hybris with SAP and non-SAP systems. In-depth knowledge of the software development lifecycle, including Continuous Integration, Build tools and configuration management. Experience in implementing agile techniques(Scrum) and methods. Exposure on the continuous integration build tools and code quality tools. AEM Development: - Lead the design and development of AEM-based web applications. - Build and maintain templates, components, and services in Adobe Experience Manager. - Develop AEM solutions that meet user needs while adhering to best practices in terms of performance, security, and scalability. - Implement custom components, workflows, and AEM integrations with external systems such as CRMs, eCommerce platforms, or marketing automation tools. - Manage and maintain AEM environments and configurations, including migrations, upgrades, and optimizations. -Salesforce Portal Development: - Design and develop custom portals and digital experiences on the Salesforce platform (e.g., Experience Cloud, Communities, or Salesforce Portals). - Implement secure and scalable solutions using Salesforce development tools, such as Lightning Components, Apex, Visualforce, and Flow. - Integrate Salesforce with AEM for personalized customer journeys and streamlined data flow. - Support the integration of Salesforce with third-party tools, ensuring smooth data exchange and API management. -System Integration: - Integrate AEM and Salesforce with other internal or external systems and services using APIs, web services, and other integration tools. - Troubleshoot integration issues and optimize the performance of integrated solutions. -Collaboration: - Work closely with product managers, UI/UX designers, and backend engineers to deliver high-quality user experiences. - Provide mentorship and guidance to junior developers, ensuring adherence to coding standards and best practices. - Engage with stakeholders to gather requirements, propose technical solutions, and estimate project timelines. -Quality Assurance: - Ensure code quality through unit testing, code reviews, and integration testing. - Identify and resolve performance bottlenecks, security issues, and bugs in both AEM and Salesforce platforms. Skills and Qualifications: Technical Expertise: Possess In-depth experience in Full Life Cycle Implementations, Re- implementation and Post Implementation Support of Hybris application. Expert in SAP Commerce Cloud (Hybris) foundational concepts, data modeling with SAP Commerce Cloud (Hybris) and integrations. Excellent knowledge in SAP Commerce Cloud (Hybris) core concepts and commerce concepts, development of extensions and add-ons. Possess Extensive Experience working with Data Hub and ImpEx scripts to integrate hybris with SAP and non-SAP systems. In-depth knowledge of the software development lifecycle, including Continuous Integration, Build tools and configuration management. Strong hands-on experience withAdobe Experience Manager (AEM)(v6.x or later) and related technologies (e.g., Sling, OSGi, JCR, Sightly/HTL). Proficiency inSalesforce Platformdevelopment, including Lightning Components, Apex, SOQL, and Visualforce. Experience withAEM-Salesforce integration. Proficiency with HTML, CSS, JavaScript frameworks (React/Angular/Vue), and web development best practices. Experience in developing custom workflows, OSGi services, and JCR queries in AEM. Strong understanding of RESTful APIs, SOAP, JSON, and integration methods. Experience with tools like Git, Jenkins, Maven, etc. Experience: - 5+ years of experience in SAP Hybris development. - 5+ years of experience in AEM platform development, knowledge of salesforce would be an added advantage - Strong understanding of content management systems (CMS) and customer relationship management (CRM) concepts. Additional Skills: - Ability to work in an Agile environment and collaborate with multiple stakeholders. - Experience in cloud platforms (AWS, Azure, etc.) is a plus. - Strong communication skills, both verbal and written. Desired Certifications: - SAP Certified Professional - Developer -SAP Commerce Cloud - Adobe Experience Manager Certification

Deliver site IT services in line with quality, reliability and cost expectations. Responsible for Margin Improvement Projects delivery. Monitor site incidents and request tickets to ensure they are resolved within SLA and that root cause is identified and addressed while coordinating with AMS partner. Ensure that critical site applications are available, patched and backed up and enabled by business and system owners. Own the roadmap for site reliability improvements and synchronize upgrades, patching and project efforts with site downtime windows. Collaborate with supporting partners and IT teams including onsite support, remote desktop support, IT outsourcing partner to maintain IT site reliability targets. Improve site digital literacy, organization IT change management and IT updates as required to support enterprise initiatives. Perform quality activities, Impact assessment, Risk assessment, NCR, CAPA for IT systems & provide IT support for instrument / equipment qualification etc. Administer system backups, check daily status, troubleshoot issues, perform root cause analysis, and resolve problems. Monitor and maintain the health of Datacenter and hub rooms. Coordinate with vendors and the Baxter global team for support and upgrades. Collaborate with Global IT Teams, Partners & vendors to ensure IT support is provided during audits. Coordinate with procurement & finance to ensure timely material delivery & invoice verification, approval & track & manage site IT assets. Coordinate, implement and maintain IT SOPs and policies at site. Life cycle management of IT assets in coordination with Global SME. Qualifications and Experience: 5+ years of experience in pharma manufacturing IT operations, preferably leading IT programs and projects or leading an IT service or solutions team within a site. Should have experience in facing corporate audits & regulatory audits for IT SOP (MHRA, USFDA, TGA, ANVISA, INVIMA etc.), demonstrating the effectiveness and efficiency of IT processes and controls. IT software or hardware implementation experience including management of on-prem systems & data centers. Proven experience working across functions and levels to drive site level IT results. Working in a multicultural and global environment shall be a preference. Self-learner, self-starter. Should be able to train & provide KT to team members & AMS partners. Education and/or Experience Any graduate with relevant work experience. Strong knowledge of IT Infrastructure, network, server (Acronis, Print Server, Winlock Server), storage, manufacturing applications, PowerApps, Trackwise, TcU, Controlled Form Systems, cloud technologies etc. Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.

As Senior Engineer-Electrical Hardware Engineering, you will develop creative Electrical solutions to challenging problems related to new product development and sustenance engineering of Surgical Solutions and Operating Room Integration Solutions. You will be responsible for hardware and PCB design & development in New product development and sustaining engineering of surgical tables, communication gateways, Video integration solutions etc. Your team will also be responsible for sustenance activities including change control, investigations for customer complaints and project work to address field issues related electrical components/ subsystems and design changes arising from component obsolescence. You will be expected to, based on significant technical expertise, architect, design and develop complex design concepts, board bring up, testing, coordinate with systems team for integration and verification / validation activities, prepare design & technical documentation and DHF details. Utilize solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Need to exhibit creativity and innovation in completing divisional and cross-functional/business unit responsibilities. You will work with global cross functional teams located across the globe. You will be expected to take on growing responsibilities for legacy products, peripherals, and strategic New Product Development activities. This position is based out of Bangalore and reporting to the R&D Manager of Global Surgical Solutions division. Essential Duties and Responsibilities: Architect, design, develop, assess technical feasibility of complex design concepts and analysis of technologies that incorporate own area of expertise on electrical hardware including but not limited to Mixed Signal circuits for Communication, DSP, Video capture and processing, Motor drives, sensing and controls, power supply etc. Ensure following of relevant international standards for design considerations and deliver robust, reliable, cost effective and efficient hardware designs. Collaborate effectively with other R&D functions such as Systems Engineering, Software and Mechanical engineering teams for timely delivery of projects. Collaborate with manufacturing partners for seamless transfer of products to manufacturing, meeting technical quality and reliability requirements. Work effectively with cross functional teams including quality, program management, procurement, manufacturing, regulatory, medical and clinical. What You'll Bring: Bachelors Degree in Electrical/ Electronics engineering with 8-12 years of experience. Medical device, diagnostics, laboratory testing product experience or similar products is preferred. Must be well versed in engineering disciplines (e.g. Mixed signal design, Power electronics, Control system, Sensors, Simulation). Must possess knowledge of related disciplines. Ability to design and implement in own area of expertise. Must be self-motivated, have good interpersonal skills. Capable of analyzing and solving complex problems through innovative thought and experience. Ability to design and influence outside of immediate scope of responsibility. Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards. Best practices for hardware design, meeting EMI /EMC standards and requirements.