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5 - 10 years
15 - 25 Lacs
Pune, Bengaluru
Work from Office
Systems Engineer (Electrical/ Electronics) Systems Engineers deliver high quality (subsystems of) products, by meeting user and business requirements, managing complexity, technical leadership, and stakeholder management. Your role: Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance. Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability. Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews. Ensuring full Product Safety Risk Management in a regulation compliant manner. Managing technological complexity of products in multi-disciplinary settings. Develops products, independently and according to own judgement, using the latest technologies and resources, often realizing systems based on unverified specifications. Makes a substantial contribution to the innovation of product and processes. Makes independent choices regarding aspects of the design. Gives reasons for changes in specifications. Formulates assignments in dialogue with customer or user. Submits ideas for future developments and providing tangible input for Technology roadmaps Develops partly and sometimes wholly new product, process or technology. Elicits, reviews, and characterizes stakeholder feedback; creates and reviews system-user interaction model with various Systems Engineering related Methods/tools You're the right fit if: Bachelors in relevant field including Electrical, Electronics, or other related science. A minimum of 5 years of experience successfully developing complex medical device (hardware, software, consumables) products for acute/emergency care/hospital markets is necessary. Have Systems Engineering certification Hands-on experience in ISO 13485, ISO 14971, ISO 20417, IEC 60601-1 and collateral standards. Hands-on experience in requirements management including, developing, deriving, flow down, tracing and prioritizing requirements. Hands-on experiences in using Model Based Systems Engineering (MBSE) Tools of Cameo and such similar tools. Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic and mechanical performance from subsystem to system level for issue resolutions. Analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions. Strong understanding of Controls and Software development process including Model-based Design approach and Test-Driven design methodologies. Solid understanding of System Verification and Validation test plan/protocols, executing V&V (Verification and Validation) (Verification and Validation) activities, generating, and analyzing test reports. Understanding of global medical device regulatory environments and clearance processes. Effective communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. Maintains strict confidentiality of sensitive information. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities, generally at the customers or suppliers locations. This is an office-based role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. If youre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips.
Posted 3 months ago
5 - 12 years
7 - 14 Lacs
Hyderabad
Work from Office
A Day in the Life As a Senior Quality Engineer you will be a key member of the Medtronic Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through precise risk assessment and management. Responsibilities may include the following and other duties may be assigned Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices. Required Knowledge and Experience B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience. Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Fair Knowledge in post market surveillance Familiar with DMAIC or DMADV(DFSS) methodologies Benefits Compensation About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here
Posted 3 months ago
5 - 12 years
7 - 14 Lacs
Hyderabad
Work from Office
A Day in the Life As a Senior Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Responsibilities may include the following and other duties may be assigned Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR. Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on EU MDR. Previous experience working in a cross-functional team environment. Hands-on experience on Risk Management, Design Controls for Medical Devices. Participate when appropriate in audits. Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards. Experience in collaborating with regulatory affairs teams for submission of safety reports. Required Knowledge and Experience B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience. Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.Familiar with DMAIC or DMADV(DFSS) methodologies. Good verbal and written communication skills including plan / report development. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation. Benefits Compensation About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here
Posted 3 months ago
4 - 7 years
12 - 15 Lacs
Pune
Work from Office
What you ll do: Practitioner in Systems Engineering, with hands-on SE experience pertaining to multi-disciplinary systems, including in regulated safety-critical industries like aerospace and automotive Practitioner on MBSE with deep hands-on experience on MBSE toolchain including SysML modeling tools such as Cameo, MagicDraw, Capella and Enterprise Architect Responsible to lead and execute full Systems Engineering development life cycle including requirements management, design, development, verification & validation, qualification & certification testing. Influence the continual improvement of the systems engineering capability, including the evolution to a Model Based Systems Engineering (MBSE) environment Apply and develop Model Based Systems Engineering (MBSE) tools, processes and techniques to develop system architectures that meet stakeholder needs Execute System Architecture ideas and demonstrate feasibility through relevant engineering calculations / predictions. Systems modelling, with exposure to MBSE, the SysML modelling language, and tools (e. g. Rhapsody, Enterprise Architect, and/or CAMEO). Exposure to industry standards like ARP4754A, IEC15288 is desirable Develop company best practices and use to create system/sub-system architectures and the decomposition, allocation of requirements into sub-systems and LRUs Planning, leading and executing requirements capture and systems architectures development using requirements capture tools (e. g. CRADLE and DOORS NG). Execute system engineering work while driving continuous improvement to fulfil project, system KPIs and meet customer satisfaction. Experenice in system modeling and validation while dealing with Multiphysics in Mechanical, pnuematic/hydraulic & Electric / Electonics, risk management to enable decision making by using robust design methodologies. DFSS GB certification / deployment is preferred. Execute multiphysics system simulations through MatLab Simulink software complying with the specifications. Drive digital transformation by leveraging data, insights and digital tools. Drive and execute a new mechanical/Electromechanical system Development through Eaton PROLaunch / PreLaunch system Engineering processes. Qualifications: Bachelors / Masters degree in Mechanical, Electronics or Systems Engineering or equivalent. INCOSE certification on Systems Engineering is an added advantage. Skills: Masters degree - 5+ years or Bachelors degree - 7+ years experience of System Engineering in Requirements engineering, Electromechanical System design, development, validation & launch This position requires 2+ years of demonstrated experience on MBSE/SysML/UML methodologies. System Engineering, MBSE, Requirements management, System Architecture, Matlab/Simulink, AmeSim, MathCAD, Verification & validation Drive for Results, Communication skills, Analysis-First Mindset, Passionate
Posted 3 months ago
4 - 7 years
12 - 16 Lacs
Pune
Work from Office
What you ll do: Practitioner in Systems Engineering, with hands-on SE experience pertaining to multi-disciplinary systems, including in regulated safety-critical industries like aerospace and automotive Practitioner on MBSE with deep hands-on experience on MBSE toolchain including SysML modeling tools such as Cameo, MagicDraw, Capella and Enterprise Architect Responsible to lead and execute full Systems Engineering development life cycle including requirements management, design, development, verification & validation, qualification & certification testing. Influence the continual improvement of the systems engineering capability, including the evolution to a Model Based Systems Engineering (MBSE) environment Apply and develop Model Based Systems Engineering (MBSE) tools, processes and techniques to develop system architectures that meet stakeholder needs Execute System Architecture ideas and demonstrate feasibility through relevant engineering calculations / predictions. Systems modelling, with exposure to MBSE, the SysML modelling language, and tools (e. g. Rhapsody, Enterprise Architect, and/or CAMEO). Exposure to industry standards like ARP4754A, IEC15288 is desirable Develop company best practices and use to create system/sub-system architectures and the decomposition, allocation of requirements into sub-systems and LRUs Planning, leading and executing requirements capture and systems architectures development using requirements capture tools (e. g. CRADLE and DOORS NG). Execute system engineering work while driving continuous improvement to fulfil project, system KPIs and meet customer satisfaction. Experience in system modeling and validation while dealing with Multiphysics in Mechanical, pnuematic/hydraulic & Electric / Electonics, risk management to enable decision making by using robust design methodologies. DFSS GB certification / deployment is preferred. Execute Multiphysics system simulations through MatLab Simulink software complying with the specifications. Drive digital transformation by leveraging data, insights and digital tools. Drive and execute a new mechanical/Electromechanical system Development through Eaton PROLaunch / PreLaunch system Engineering processes. Should have working experience with CAD, analytical & analysis tools (Creo, Matlab/Simulink, AmeSim, MathCAD) Should have proficiency in advanced problem-solving techniques. Qualifications: Bachelors / Masters degree in Mechanical, Electronics or Systems Engineering or equivalent. INCOSE certification on Systems Engineering is an added advantage. Skills: Masters degree - 10+ years or Bachelors degree - 12+ years experience of System Engineering in Requirements engineering, Electromechanical System design, development, validation & launch This position requires 5+ years of demonstrated experience on MBSE/SysML/UML methodologies. System Engineering, MBSE, Requirements management, System Architecture, Matlab/Simulink, AmeSim, MathCAD, Verification & validation Drive for Results, Communication skills, Analysis-First Mindset, Passionate
Posted 3 months ago
4 - 6 years
6 - 8 Lacs
Chennai
Work from Office
About The Role : Should be able to interpret the Electrical Schematic diagram, Panel, Cables , Component Selection ( MCCB, Switch gear, Breaker rely , Cable Harness) components Should have experience in , UPS, Backup, Battery, DCN controls, CT Module, Network, electronic Bus. Should have experience in Senors ( Pressure, Temp, smoke), PLC, Digital & Analog Components Previous experience in Commissioning & Troubleshooting will be added advantage. Knowledge of IEC, UL, EN Standards Basic knowledge of applying Q tools like DMAIC, DFSS will be added advantage. Able to download & investigate on , why alarm has triggered false message. Investigate failures reported from turbines in field by collaborating with site technicians and design engineers. Drive root-cause analysis and identify impact on fleet Primary Skills Make alignment with all affected stakeholders like:Module owners, service, Construction, legal Identify short and long-term actions to reduce effect of failure Drive development of improvement solution. Testing specifications for solution. Prepare inputs for customer and stakeholder communication Field experience in Wind Industry especially WTGs will be preferred Experience with DMAIC cycle, 6-Sigma, SCRUM and gate models would be an advantage.
Posted 3 months ago
3 - 6 years
6 - 10 Lacs
Pune
Work from Office
What you ll do: "If you desire to be part of something special, to be part of a winning team, to be part of a fun team - winning is fun. We are looking forward to have a Lead Engineer-MV Switchgear Design in Eaton s Electrical Systems and Solutions business, based in Pune , India. In Eaton, making our work exciting, engaging, meaningful; ensuring safety, health, wellness; and being a model of inclusion & diversity are already embedded in who we are - it s in our values, part of our vision, and our clearly defined aspirational goals. We are looking for motivated professionals with strong skills in Cost-out/ VAVE/ New Product development for Medium Voltage Switchgear (RMU, GIS, SIS). The products developed would be for Europe and Middle East Markets. Success in this position requires the ability to work effectively in a collaborative environment, strong motivation for pursuing project objectives and the ability to learn new techniques, Tools, Processes for new Product Development Cycle. " "A. Perform Cost-out/ VAVE of MV Switchgears B. Design and Develop MV Switchgear (RMU, AIS, SIS, GIS) meeting customer requirement, cost target and Market related technology. C. Coordinate with Global stakeholders and Drive project execution through Design, testing and implementation phase D. Technical ownership of the project. Ensure product compliance to global design standards such as IEC, TEDAS etc. E. Continuously improving design to achieve best practice standards, Drive Modeling, and simulation 1st approach to meet requirements. F. Providing innovative and creative Engineering solutions that meet company and customer quality standards G. Delivering engineering solutions on time, considering the most cost-eff active utilization of people, materials and plant while maintaining high quality standards H. Technical documentation of design in proper formats, tests as per IEC 62271-1, -100, -200, -102 standard I. Making Bill of material and calculate transformer costing, Cost reduction. J. Release of Production documents such as BOM, design, Test reports, Tech manuals etc. K. Preparing and reviewing of Routine and type test L. Design lead responsibility on Projects which would also involve coaching and mentoring team members to achieve project goals M. Visit vendors to ensure timely delivery and product quality N. Deployment of DfX/DfSS principles on projects O. Participate in design reviews, both customer and internal as required P. Review reliability predictions, and Design Failure Modes and Effects analysis (FMEA) and structural/thermal/CFD results Q. Participate in multi-discipline concurrent development and corrective action teams Qualifications: B. E. / B Tech / M Tech (Mechanical) B. E. /B Tech - 9 Years + M Tech - 6 Years+ of experience in design, development, manufacturing process and testing of MV Switchgear. Skills: 1. Lead overall architecture, busbar design, mechanism design, CT VT selection, relay selection, structural calculations. 2. Bushings selection and design. 3. Thermal management in MV Switchgear. 4. Overall Switchgear manufacturing process knowledge 5. Working knowledge of CAD softwares such as Solid works/ CREO 6. Knowledge on PLM softwares such as Enovia 7. Knowledge of Switchgear routine testing & type testing procedure and Practical experience in testing 8. Experience of New product development Stage gate process 9. Hands on experience in product development leveraging DfX methodology 10. Having IEC 62271-1, -100, -200, -102 compliant product knowledge will be considered a plus Excellent verbal and written communication skills, Problem solving skills, Working in ambiguity, process management
Posted 3 months ago
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