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4.0 - 8.0 years

10 - 15 Lacs

bangalore rural, bengaluru

Work from Office

Job Discretion: JL 5 - Sr Associate role - Electrical or Mechanical Engineering with 5+ years of experience . 3+ relevant years of experience in Design Control of Medical Devices . Life cycle management, making decisions in change management. Change management - Cost reduction, process improvement. Regulatory affairs MDR to EMUDR , follow the regulatory & statutory requirements Work with cross functional teams. Excellent written & verbal communication. Act as project lead – coordinate with different teams - Design Control , MTO, Service, Regulatory Affairs . Team lead experience. Good to have experience in ophthalmology . Consumables and Accessories experience. People with experience in Sterile Barrier/Packaging, Biocompatibility, and sterilization . They have min understanding of it.

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10.0 - 12.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Maintains and expands QA/ QS and supervisory knowledge in areas applicable to Quality Engineering. Job Description 6. Job Responsibilities . Manages Quality Engineering staff and guides the Quality groups in BD TCI in support of product development. . Leads development, sustenance, and continual improvement of quality systems in compliance with 21 CFR 820, EUMDR, and ISO 13485 quality systems with a specific focus on the design control requirements. . Runs multiple projects directly while managing other quality engineering resources running separate projects. . Ensures compliance with all local, state, federal regulations, and BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. . Leads design control compliance within the phase gate product development process as specified for the business. Lead evolution and improvement of the product development process. . Leads or supports cross-functional planning, coordination, and reviews. Initiates and directs QA/ QS programs for effective introduction of new products and processes to fulfill the strategic plan. . Leads Risk Management activities for products under design authority. . Supports quality initiatives for Site issues. Work closely with Design Owner and Manufacturing sites globally to resolve customer complaint issues by identifying root causes and developing corrective actions. . Act as a role model/Change ambassador to establish Inspire Quality initiatives through close collaboration with many partners to influence and lead the Quality strategy . Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA) 7. Knowledge and Skills a. Knowledge . Bachelor's degree in mechanical engineering or related discipline. . Advanced knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, ISO 14971, EUMDR etc.), and quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards. . Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements. . Advanced leadership, motivational, and team building skills, with the ability to lead organizational change. . Advanced interpersonal skills with the ability to manage, motivate, and influence both up and down the organization. . Understanding of clinical setting and ability to understand customers quality and regulatory needs. . Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast paced environment. b. Skills . Minimum 5 years of experience in supervising technical/ quality professionals. . Minimum 10 years relevant experience in design quality, quality record documentation, quality system requirements, GMP compliance, quality auditing, and CAPA systems, including or other applicable combination of education and experience. Required Skills Optional Skills . Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift

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2.0 - 4.0 years

0 - 0 Lacs

khandala

Work from Office

Role & responsibilities Exposure Material Handling Conveyor Systems, Robotic Integration Systems, Gantry Systems, Powertrain assembly lines and e mobility projects in automotive industry Purpose of Job Controls BOM selection and E Plan electrical drawings Key Responsibilities Electrical architecture preparation per customers standards. Preparation of the electrical drawings for the systems System Hardware design, Control Panel design, Component Selection of switchgears, relays, arrays and sensors. Calculations of Electrical system Preparation of BOM (bill of Material) Prepare a high-level flow cart per the software architecture Testing of a design system on the shop floor if required Should work on PLCs / CNCs, HMIs, drives, servo, etc. for concept proving. technical requirements & customer's standards Knowledge of Fieldbus like Ethernet TCP/IP, Profibus, Profinite, Serial Communication Schematic Diagram, Signal Line Diagram, Generation of Terminal Detail To follow IMS Process, Procedure, guideline, OCP and update department lists and records , Risk & opportunity, HIRA, aspect- Impact, dept. obj. To follow the safety rules and regulations. To follow the guideline for waste management & take the initiative to conserve the natural resources. Preferred candidate profile Minimum Qualification BE/Diploma Electrical, Electronics and Instrumentations Minimum Experience 2-5 years

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2.0 - 6.0 years

13 - 18 Lacs

gurugram

Hybrid

Work Flexibility: Hybrid What will you do : Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Supply Chain, Manufacturing) to execute product transfers. Responsible for process development and all process documentation (SOPs, Work Instructions, BOMs, Routers, PFMEAs, Control Plans) is reviewed, updated, and transferred Prepare and review PPAP documents (PFMEA, Control Plans, Process Flow Maps, , Process Capability Study, inspection plans etc) and support method qualifications Develop and qualify gages: perform Gage R&R and MSA studies Review and qualify manufacturing processes, ensuring regulatory and quality compliance Coordinate with supplier quality and sourcing teams when components or suppliers are impacted. Conduct equipment qualification, process validation (IQ/OQ/PQ), and test method transfers Perform technical reviews and gap analyses to assess receiving site readiness Ensure compliance with regulatory, quality, and company standards during transfer activities Support root cause analysis and troubleshooting during scale-up or post-transfer issues Maintain detailed records of transfer activities and support audit readiness What you will need : Basic Qualification : Bachelors degree in Engineering (Mechanical, Electronics, Mechatronics, Electrical, Industrial, or equivalent). 2-6 years of experience in manufacturing, process engineering, or product transfers (preferably in medical device, pharmaceutical, or regulated industries). Experience with process validation, design control, and quality systems (Preferred ISO 13485, FDA , etc.). Strong analytical, organizational, and communication skills. Ability to work effectively across global, cross-functional teams Preferred Skills : Familiarity with Lean, Six Sigma, or other process improvement methodologies is a plus. Proficiency with tools such as Minitab, SolidWorks, SAP/ERP, or PLM systems Travel Percentage: 10%

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2.0 - 15.0 years

0 Lacs

chennai, tamil nadu

On-site

Job Description: As a Mechanical Engineer with 5+ years of design control and project management experience, you will have the following responsibilities: - Lead multiple / complex sustenance engineering projects and coordinate with cross-functional teams to deliver design solutions. - Contribute to/lead Design change controls, Design reviews, and Design transfer. - Write and analyze technical reports, complying with standards such as 21 CFR Part 820.30, ISO 13485, and ISO 14971. - Develop and release design control documentation, including verification protocols and Design History File. - Apply engineering principles to propose and implement solutions, optimize product design, material selection, and features. - Coach and mentor junior engineers and technicians on project deliverables. Qualifications for VBA Developer position include: - Bachelor's degree in engineering, Computer Science, Information Technology, or related field. - 5-6 years of experience as a VBA Developer with proficiency in Microsoft Excel and VBA programming. - Knowledge of relational databases, SQL queries, and strong problem-solving skills. - Ability to work in a team-oriented environment with attention to detail. For the role of Design & Development of Medical, Appliances, or Electro-Mechanical systems, the required skills are: - 4 to 7 years of experience in NPD/Sustenance projects for Medical Laboratory Instruments, Appliances, or Electromechanical systems. - Proficiency in medical industry legacy product sustenance, material selection, manufacturing processes, and Creo/Windchill PDM system. - Knowledge of Engineering change control process, medical standards ISO 13485 & ISO 14971, and strong interpersonal skills. As a Project Manager with 12+ years of overall work experience and 5+ years of Project management experience, your responsibilities will include: - Technical knowledge of projects executed, customer-facing communication, and hands-on experience with MS Office tools. - Ability to manage multiple tasks, knowledge of RCA and CAPA, and problem-solving skills. The responsibilities for Windchill include: - Creating, revising, releasing parts and documents in Windchill according to defined requirements. - Updating BOM structure, creating change orders, assigning reviewers and approvers, and releasing Change Orders in Windchill. Please note that interested candidates can share their CV to Katherinesylvia.k@hcltech.com with details of Current Company, Current CTC, Expected CTC, Notice Period, and Location.,

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1.0 - 2.0 years

2 - 4 Lacs

mumbai

Work from Office

What this job involves You will be responsible to ensure all necessary utilities are being given to the occupants/tenants. You will be responsible for all drawing submissions and approvals to be maintained for fitout work. The contractor will coordinate with you for all minor execution issues. Building maintenance and upkeep will be one of your KRA. Your key deliverables will be: Maintain records of all building drawing. Make sure all instruction guidelines are being followed as per the fitout manual. Provide necessary permits (Night work, hot work, height work). Coordinate for all necessary security arrangements for execution of fitout activities. Monitor and control work in progress as per approved plan by the client. Ensure completion of Snagging and De-snagging work of flats Common area. Ensure all safety requirements are being followed at the site. Advise contractor on minor execution issues. Ensure that all work meets client design control specifications. Daily visit to ongoing fit-out work for checking of civil work layout. Working closely with management to help improve and maintain the building in clean and maintenance free condition. You will be meeting with all clients who are going to start the fit-out work to resolve queries of clients regarding the working procedures, instruction and for material handling as per approved drawings and other documents related to fit out work and operation activities. Maintain a fitout tracker. Providing the clients with suitable energy conservation plans. Coordinate and maintain the as-built drawing and transition document library. Work closely with the regional RO HO SME/ Training teams and ensure closures of all required reports. Facilitate the services under the Slogan No Safety No Work. Site dynamics: 1. Work Schedule: 2. Site team: e.g.: Property Manager +2 3. Other details if any. Reporting: You will be working with our operations team and reporting to the Property Manager. Sound like you Here is what were looking for: Being Analytical and Meticulous Your role will involve coordination with various teams/ vendors. You will be paying attention to detail and have excellent problem-solving skills. You will be using logic to trouble-shoot problems; and assign and monitor maintenance projects. You should have a good knowledge of the working procedures for fitout. Qualifications You will have a Degree Diploma or relevant educational background in Civil Engineering with minimum 1-2 years of work experience. On-site Mumbai, MH

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7.0 - 12.0 years

16 - 18 Lacs

pune

Work from Office

Position Overview: We are looking for an experienced Asst. Manager - Design & Engineering, for Dry Type Transformers and Chokes to lead our engineering design team . The role involves overseeing the design and development of low-voltage and medium-voltage dry type transformers, reactors, and chokes for industrial, renewable, and utility applications. The ideal candidate will have deep technical expertise, strong knowledge of applicable standards, and proven leadership skills to ensure high-quality, cost-effective, and innovative product designs. Roles & Responsibilities: Support Logical and physical schematic development Must know 2D & 3D Engineering software like Capital , Solid works AutoCAD etc. Maintain design version control as per customer drawing revision. Responsible person to release drawings to production department Create and maintain program specific foundation documents Develop and/or direct manufacturing print development and release Must have thorough knowledge of PPAP , APQP , FMEA , MSA and SPC and other tools Must have practical knowledge of all process of manufacturing. Co-ordination with customer and production regularly for drawing updation. Liaising with Global / Local material supplier for technical details Must be able to communicate with customers on the technical requirements, be able to discuss, participate and negotiate in finalizing technical requirements and acceptance methodologies. Must be able to participate in responses & workout on VA/VE. ISO/TS/ IEC knowledge is must. Also to be conversant with similar industry standards. Must have knowledge of converting design excel calculations into manufacturing drawings and customer general arrangement drawings. Lead the complete design process for dry type transformers (cast resin, VPI, etc.) and chokes/reactors. Perform and validate electromagnetic, thermal, dielectric, and mechanical calculations. Develop detailed design drawings, BOMs, and technical specifications. Ensure compliance with IEC, IS, ANSI, IEEE, and other relevant standards. Drive design optimization for efficiency, size reduction, thermal performance, and noise reduction. Manage, mentor, and develop a team of design engineers. Review and approve designs, calculations, and technical documents prepared by the team. Allocate tasks, set priorities, and monitor progress against project timelines. Provide training on new tools, materials, and design methodologies. Evaluate and adopt new materials, insulation systems, and winding technologies. Implement simulation tools (FEA, electromagnetic, and thermal analysis) to improve design accuracy. Promote standardization and modular design approaches to reduce cost and lead time. Work closely with manufacturing, testing, quality, and supply chain teams to ensure design feasibility and manufacturability. Support sales and tendering teams with technical inputs for proposals, RFQs, and customer queries. Participate in customer discussions, clarify technical requirements, and provide engineering support during FAT/SAT. Technical Skillsets: Strong knowledge of dry type transformer and choke design principles. Expertise in insulation systems (cast resin, VPI), cooling methods, and mechanical structures. Proficiency in design and simulation tools (e.g., ANSYS, Maxwell, MagNet, MATLAB, AutoCAD, or similar). Familiarity with IEC 60076, IEC 60726, IEEE, and other applicable standards. Swedish MNC, located at Chakan MIDC, is looking for Capable Design Professionals, from the Transformer industry willing to join a growth oriented team, with learning and development as key to success, may email your resumes at xpert.consult03@gmail.com. xPert Consulting Pune #9764335759

Posted 6 days ago

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16.0 - 25.0 years

35 - 100 Lacs

bengaluru

Hybrid

Job Requirements Job Summary We are seeking a Technical Manager with deep domain expertise in medical imaging hardware and systems. The selected candidate will lead technical engagements across the full product lifecycle, focusing on design, integration, compliance, and end-to-end lifecycle management of systems such as Diagnostic X-ray, Computed Tomography (CT), Image Guided Therapy (IGT), Mobile Surgery and Mammography Systems. This is a high-impact role requiring deep technical expertise and leadership, strong regulatory acumen, hands-on experience, and stakeholder management and project management in complex medical hardware systems. Key Responsibilities Lead technical planning, development, and integration testing of imaging hardware systems. Oversee product lifecycle management (LCM) and engineering change processes for medical imaging platforms. Act as the technical liaison between the R&D and cross-functional teams of the client and engineering teams of Quest Global. Ensure that product development and updates comply with applicable regulatory, quality, and safety standards, including FDA, EU MDR, IEC norms etc. Own and maintain Design History Files (DHFs), Risk Management Files (RMFs), Device Master Records (DMRs), and Technical Files. Lead Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and other hazard mitigation efforts. Manage Verification and Validation (V&V) of hardware components and systems in compliance with regulatory standards. Conduct and support the failure investigation, root cause analysis (RCA) and Corrective and Preventive Action (CAPA) processes for field issues. Drive design decisions using risk-based approaches and ensure alignment with clinical use cases and intended use. Facilitate client audits, internal quality reviews, and regulatory inspections as needed. Work Experience Essential Experience & Skills Bachelor’s or master’s degree in electrical, Electronics, Biomedical or Mechatronics streams 18+ years of experience in medical device hardware engineering, specifically in diagnostic imaging modalities like Diagnostic X-ray, Computed Tomography (CT), Image Guided Therapy (IGT), Mobile Surgery and Mammography Systems. Solid track record of leading hardware/system engineering activities in regulated environments. Good knowledge of international and regional regulatory frameworks and standards, including FDA, EU MDR, Other Country Specific Regulations, IEC 60601 series, ISO 13485 etc. Experience in regulatory submissions (e.g., FDA 510(k), EU Technical Documentation) etc. Proficient in working with PLM systems (e.g., Windchill, Teamcenter) and quality documentation platforms. Strong knowledge of safety standards, electrical and thermal risk controls, and human factors engineering. Deep understanding of design controls, risk management, verification & validation protocols, and traceability matrices. Provide technical leadership and mentorship to junior engineers. Stay up-to-date with advancements in Medical Device technologies and regulatory changes Excellent communication and articulation skills Strong analytical and problem-solving abilities Desirable Experience & Skills Ability to interact with Notified Bodies, FDA inspectors, and regulatory consultants. Exposure to post-market surveillance, UDI implementation, and real-world evidence (RWE) reporting. Experience with audit readiness, remediation projects, or FDA consent decree programs is a plus.

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16.0 - 25.0 years

35 - 100 Lacs

pune

Hybrid

Job Requirements Job Description: Sr. Technical Manager Job Summary We are seeking a Sr. Technical Manager with deep domain expertise in medtech products and devices. The selected candidate will lead technical engagements across the full product lifecycle, focusing on design, integration, compliance, and end-to-end lifecycle management of diagnostic imaging and critical care products/systems. This is a high-impact role requiring deep technical expertise and leadership, strong regulatory acumen, hands-on experience, and stakeholder management in complex medical hardware systems. Key Responsibilities Lead technical planning, development, and integration testing of imaging hardware systems. Oversee product lifecycle management (LCM) and engineering change processes for medical imaging platforms. Act as the technical liaison between the R&D and cross-functional teams of the client and engineering teams of Quest Global. Ensure that product development and updates comply with applicable regulatory, quality, and safety standards, including FDA, EU MDR, IEC norms etc. Own and maintain Design History Files (DHFs), Risk Management Files (RMFs), Device Master Records (DMRs), and Technical Files. Lead Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and other hazard mitigation efforts. Manage Verification and Validation (V&V) of hardware components and systems in compliance with regulatory standards. Conduct and support the failure investigation, root cause analysis (RCA) and Corrective and Preventive Action (CAPA) processes for field issues. Drive design decisions using risk-based approaches and ensure alignment with clinical use cases and intended use. Facilitate client audits, internal quality reviews, and regulatory inspections as needed. Own Technical Decisions; Provide Technical Guidance and Direction Accountable for issue closure as per the committed leadtime with customer Ensure Quality of Delivery - First Time Right (FTR) Work Experience Essential Experience & Skills Bachelor’s or master’s degree in electrical, Electronics, Biomedical or Mechatronics streams 18+ years of experience in medical device hardware engineering, specifically in diagnostic imaging and critical care products/systems. Solid track record of leading hardware/system engineering activities in regulated environments. Good knowledge of international and regional regulatory frameworks and standards, including FDA, EU MDR, Other Country Specific Regulations, IEC 60601 series, ISO 13485 etc. Experience in regulatory submissions (e.g., FDA 510(k), EU Technical Documentation) etc. Proficient in working with PLM systems (e.g., Windchill, Teamcenter) and quality documentation platforms. Strong knowledge of safety standards, electrical and thermal risk controls, and human factors engineering. Deep understanding of design controls, risk management, verification & validation protocols, and traceability matrices. Provide technical leadership, skill development, mentoring and handholding of junior engineers. Stay up-to-date with advancements in Medical Device technologies and regulatory changes Excellent communication and articulation skills Strong analytical and problem-solving abilities Desirable Experience & Skills Ability to interact with Notified Bodies, FDA inspectors, and regulatory consultants. Exposure to post-market surveillance, UDI implementation, and real-world evidence (RWE) reporting. Experience with audit readiness, remediation projects, or FDA consent decree programs is a plu

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2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

As an R&D Executive at PTC - MORAIYA, your primary responsibility will be characterizing materials and developing/qualifying packaging systems including primary, secondary, and tertiary packaging. You will be tasked with completing design control deliverables and ensuring compliance with relevant regulatory requirements for submission. Additionally, you will provide post-launch troubleshooting support for complex products and develop various drug delivery devices such as Pen Devices, Auto Injectors, DPI, and pMDI while maintaining a deep understanding of regulatory expectations. Your role will involve compiling essential documents such as User Requirement Specifications (URS) and design control/history files for combination products. You will be responsible for conducting functional performance studies of devices, coordinating with vendors to execute non-disclosure agreements, and finalizing trade dress. Furthermore, you will source new packaging materials, develop new vendors, track packaging material availability and procurement, and support cost evaluation processes. In this position, you will prepare lab notebooks, Packaging Development Reports, Bill of Materials (BOMs), and batch Packaging Records for various stages from engineering batches to commercial batches. You will also be involved in preparing specifications, standard test procedures for packaging material components, Standard Operating Procedures (SOPs), and guidelines. Troubleshooting issues related to the process and usage of packaging materials, conducting SAP-related activities, managing change control procedures, and responding to packaging-related queries from regulatory authorities will be part of your responsibilities. Moreover, you will design pack configurations for commercial launch based on marketing requirements, conduct transportation studies, revise artworks for Reference Listed Drug (RLD) changes, and optimize pack configurations to meet marketing needs, cost considerations, and automation requirements. Your role will require attention to detail, regulatory compliance, and effective communication with internal and external stakeholders to ensure the successful development and implementation of packaging systems.,

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5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufacturing considerations. You will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. Accuracy in regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance will be critical in this position. Collaboration with R&D, Quality, Clinical, and Manufacturing teams is essential to align regulatory strategies with product development. You will also support design verification and validation activities, including human factors engineering (HFE) and risk management. Your role will involve providing regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. By leveraging your expertise in regulatory affairs, you will contribute significantly to the success of regulatory processes for biosimilar combination products.,

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3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru - BDC and will be an on-site role. In this role, you will have the opportunity to: Author, review, and executesystem-level test protocolsto validate design changes. Ensure test coverage foraccuracy,performance,throughput,carryover, andlinearityEtc. requirements. Analyze test data and generatestatistically sound reportsto support design verification and release decisions. Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes. Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact. Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals. The essential requirements of the job include: Bachelor's or Master's degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field. 3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems. Strong understanding ofdesign control,risk management, andreliability engineering. Proficiency instatistical analysisand tools for data interpretation. Familiarity withDFMEA,ISO 14971,IEC 60601, andFDA QSR. Experience insetting up experiments using external sensors and data acquisition systemssuch asLabVIEW, NI DAQ, or similar platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus. Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II). It would be a plus if you also possess previous experience in: Experience in medical device design & development is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

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3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru - BDC and will be an on-site role. In this role, you will have the opportunity to: Author, review, and executesystem-level test protocolsto validate design changes. Ensure test coverage foraccuracy,performance,throughput,carryover, andlinearityEtc. requirements. Analyze test data and generatestatistically sound reportsto support design verification and release decisions. Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes. Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact. Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals. The essential requirements of the job include: Bachelor's or Master's degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field. 3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems. Strong understanding ofdesign control,risk management, andreliability engineering. Proficiency instatistical analysisand tools for data interpretation. Familiarity withDFMEA,ISO 14971,IEC 60601, andFDA QSR. Experience insetting up experiments using external sensors and data acquisition systemssuch asLabVIEW, NI DAQ, or similar platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus. Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II). It would be a plus if you also possess previous experience in: Experience in medical device design & development is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

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3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At HemoCue, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we've been advancing what's possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count. The Development engineer, Electronic at HemoCue is responsible for finding replacement components, update the design documents and together with the team test the design change within the Sustaining Engineering department. This position is part of the R&D team located in Bangalore and will be on-site. At HemoCue, our vision is to do things easier, to do things better, and to do them right. You will be a part of the Sustaining Engineering team and report to the Director of Sustaining Engineering (located in at headquarter in Sweden). You will be responsible for planning, design, implementation and documentation of obsolete electronic components. If you thrive in a fast-paced environment, enjoy working independently but also cross-functionally and want to work to build a world-class R&D organization-read on. In this role, you will have the opportunity to: Perform product support activities for current products, primary instrument activities Cross-functional work with operations department and/or subcontractor by solving problems, coordinating and approving changes to HemoCue products Execute and/or participate in product lifecycle activities, such as CAPAs, engineering change orders, cost down activities and general sustaining engineering activities The essential requirements of the job include: University degree: Master of Science, Bachelor of Science or Engineering or equivalent work experience within electronics and at least 3 years of work experience Knowledge of analog and digital electronics Experience from working with electronics schematics & PCB's and using tools such as Altium Designer Your main communication language will be English Knowledge about ISO 13485, QSReg and Design Control It would be a plus if you also possess previous experience in: Experience from product development of medical devices Experience from design changes for medical devices Join a winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

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3.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru - BDC and will be an on-site role. In this role, you will have the opportunity to: Author, review, and executesystem-level test protocolsto validate design changes. Ensure test coverage foraccuracy,performance,throughput,carryover, andlinearityEtc. requirements. Analyze test data and generatestatistically sound reportsto support design verification and release decisions. Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes. Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact. Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals. The essential requirements of the job include: Bachelor's or Master's degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field. 3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems. Strong understanding ofdesign control,risk management, andreliability engineering. Proficiency instatistical analysisand tools for data interpretation. Familiarity withDFMEA,ISO 14971,IEC 60601, andFDA QSR. Experience insetting up experiments using external sensors and data acquisition systemssuch asLabVIEW, NI DAQ, or similar platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus. Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II). It would be a plus if you also possess previous experience in: Experience in medical device design & development is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

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6.0 - 10.0 years

11 - 16 Lacs

bengaluru

Work from Office

Youll make a difference by Develop hardware controls for innovative rail vehicles as part of a collaborative team. Responsible for the electrical integration of subsystems. Design control and power circuits. Develop cost-optimized hardware solutions during the concept phase in close cooperation with software developers. Define relevant system interfaces in collaboration with internal and external stakeholders. Create circuit diagrams and documentation for electrical assembly using advanced CAD software. Generate electrical wire lists, BOMs, and component specifications. Continuously expand your knowledge to take on increasingly complex hardware development tasks. Manage subcontracting mandates, including definition, monitoring, and validation. Drive continuous improvement and feedback management (REX) based on previous projects. Desired Skills: Bachelors or masters degree in electrical engineering. 6 to 10 years of experience in hardware or electronics control development. Preferably experienced in safety-relevant control systems for rail vehicles. Strong knowledge of electrical connectors, switchgear, pushbuttons, switches, terminal blocks, cables, and I/O units. Familiarity with applicable EN/IEC standards for electrical components in rolling stock. Mandatory experience in electrical design for rolling stock (Metro/Commuter Rail/Locomotive), including complete design and development of at least one train set or locomotive. Proficient in designing discrete control circuits and electrical power supply circuits. Extensive experience with modern E-CAD tools such as Zuken E3, COMOS, EPLAN, ELCAD, or similar. Passionate about solving complex problems and developing effective system solutions. Willingness to travel within India and abroad for train production, testing, and commissioning activities. Excellent communication and mentoring skills. German Language skills are a plus. Commitment to meeting deadlines and delivering high-quality work.

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3.0 - 7.0 years

0 Lacs

andhra pradesh

On-site

Job Description: To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account. Varex Imaging is hiring a System Software Engineer in Test in the fast-growing X-Ray Imaging Components division. The Software Engineer in Test will bring real-world experience to our team by helping to develop automated integration and robustness testing to ensure system software performs as designed. We are looking for candidates that will thrive in a fast-paced, self-directed environment and can hit the ground running in a critical division of our company. There will be opportunities to work both individually and as a team. This position involves writing C++ software tests that will interact with x-ray hardware components. Responsibilities: - Develop and execute automated test software to ensure product reliability and performance. - Work closely with development, SWQA, and DevOps teams to integrate automated testing into the software development lifecycle and ensure quality checkpoints throughout. - Strong knowledge of software testing methodologies, including unit, functional, integration, and reliability testing. - Develop lab testing strategies and ensure lab automation is performant and consistent. - Promote good software testing practices at every stage of development. - Design, build, and unit test object-oriented software in a collaborative environment. - Understand product development processes including Change Control, Design Control, and SDLC. - Excellent oral and written communication skills. - Ability to interface and communicate with team members across time zones. - Must be able to work with minimal supervision. Requirements: - At least a B.S in Software Engineering or Computer Science. - 3+ years of relevant work experience. - Fluency in C++ is required. - Experience with CI/CD. - Experience with Google Test or related technologies is beneficial. - Experience with both Microsoft and Linux operating systems. - Experience with Software Control Management systems, preferably git. - Ability to diagnose issues using log files. - Solid understanding of system-level software (drivers, firmware, networking, wifi, and test applications) is highly desirable. - Passion for developing efficient, testable, and well-documented code. - Prior work with imaging products or designing software products in an FDA or other regulated industry is highly desirable. What we offer: - A unique opportunity to become part of a growing organization in India being part of a global market leader in X-ray imaging components. - Excellent development potential. - An international work environment with global teams collaborating on various projects across several countries. - Competitive compensation package including participation in Varex incentive plans. - Corporate Health Benefits. - Additional benefits will be added as we grow. Time Type: Full time Job Type: Regular Work Shift: N/A Salary: Not specified,

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12.0 - 15.0 years

7 - 9 Lacs

bengaluru

Work from Office

Role & responsibilities: Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Minimum Qualification & Work Experience Required: Bachelor’s in Civil Engineering is required. Atleast 12 years’ of overall experience with 5 years’ of relevant construction supervision experience of water supply and used water infrastructure projects.

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3.0 - 8.0 years

8 - 17 Lacs

chennai

Hybrid

Role & responsibilities 1. Hands on experience in design controls requirements in medical device industry 2. Design verification, Design Outputs etc. 3. Experience developing test protocols and test plans 4. Strong Communication (written & verbal). 5. Ability to collaborate effectively with cross-functional teams 6. Knowledge in PLM/ALM tools (SAP, Team Centre, Windchill, etc.) 7. Technical knowledge of engineering statistics (Minitab Preferred)

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2.0 - 10.0 years

0 Lacs

chennai, tamil nadu

On-site

Join a team that values innovation, growth, and impactful work. Don't miss the chance to work with cutting-edge projects in SME and be a part of something transformative! Drive Date: 26th July Saturday (9AM-2PM) Skills Required: - Experience in DHF remediation - Proficiency in Design Control, Design Verification, and Design Validation - Expertise in WindchillPLM in the medical domain Venue Location: HCLTech Elcot Sez, New Cafeteria 2nd Floor, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119 Position: Mechanical Design (Lead, Technical Lead) Experience: 2.5-10 years Job Location: Chennai Job Description: - B.E / B.Tech or higher education in Mechanical Engineering - Sustaining Engineers should have 3 to 7 years of experience in Medical Device Design Controls, Design Verification & Validation - Proficient in Design Control processes for Medical Devices - Led Change Qualification projects for medical devices, working with multi-cultured CFT - Experience in developing test protocols and test plans - Ensures quality of deliverables, including design, data summary and interpretation, and report generation - Expertise in Mechanical Engineering basics - Proficient in Risk Management (Proactive risk identification and mitigation planning) - Self-motivated and capable of working independently with strong project management skills - Knowledge of ISO13485 would be an added advantage - Excellent Oral and written Communication skills with proven Technical writing skills and interpersonal skills Software Tools: - SolidWorks, 2D Tolerance Stackup, MS Word/Excel/PowerPoint Skill 2 Job Description (DHF Remediation): - Experience in gap assessment processes such as Testing gap assessment, Standards gap assessment, Requirements gap assessment - Knowledge in Design History File remediation Skill 3 Job Description (WindchillPLM - Medical Domain): - Proficiency in WindchillPLM in the medical domain, BOM structure, and Change order process Interested candidates can share their CV to Katherinesylvia.k@hcltech.com with the following details: Current Company, Current CTC, Expected CTC, Notice Period, Location. CONSIDER THIS AS CALL LETTER,

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3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a Senior Analyst in R&D Compliance Specification at Kimberly-Clark, you are a dedicated learner and a natural leader who takes initiative to improve processes and engage others in the journey. Your commitment to integrity and quality is unwavering, ensuring that your responsibilities contribute to long-term success. By joining our team, you will play a crucial role in enhancing healthcare for billions of individuals worldwide, starting with your efforts. Reporting to the R&D Center of Excellence Leader, you will be an integral part of the EM R&D Team. Your main responsibility will be to ensure that all products and processes adhere to regulatory standards and internal specifications. This entails developing, implementing, and maintaining compliance programs while managing product specifications to uphold quality and consistency within the Kimberly-Clark Quality Management System. Your role is vital in supporting business objectives and embodying the One K-C Behaviors and values. Key responsibilities include developing and implementing compliance programs to meet regulatory requirements, overseeing design control activities to ensure products align with regulatory and quality standards, managing change control processes, harmonizing procedures to promote efficiency, monitoring internal processes for compliance, and maintaining product specifications. Additionally, you will collaborate with cross-functional teams, conduct training sessions on compliance practices, stay updated on regulatory changes, prepare compliance reports, investigate issues, and support audits. In this role, you will act as a liaison between the R&D and Quality departments, collaborate with Quality Assurance teams, conduct training sessions, and facilitate process harmonization initiatives. You will also be responsible for monitoring internal processes to ensure compliance with industry standards and regulations. Your ability to build collaborative relationships, drive solutions, and maintain integrity in all communications is essential to succeed in this position. Based in Ho Chi Minh City, Vietnam, you will work in manufacturing facilities, where you may be exposed to various environmental conditions. Proper personal protective equipment must be worn at all times to ensure safety. Your commitment to self-development, collaboration, and integrity will be key to thriving in this dynamic role. To qualify for this position, you should hold a Bachelor's degree in a relevant scientific field and have at least 3 years of experience in compliance management, quality assurance, or a related field. Strong knowledge of regulatory requirements, attention to detail, organizational skills, analytical abilities, effective communication, and proficiency in compliance management tools are essential skills for success in this role. At Kimberly-Clark, we offer a range of benefits to support your health, well-being, and professional development. From medical, dental, and vision coverage to flexible savings accounts and diverse income protection options, we prioritize your holistic well-being. Additionally, we provide support for educational pursuits, childcare, and other personal needs to ensure a fulfilling work experience. If you are ready to contribute to a global leader in healthcare and consumer products, click the Apply button to start the application process. We look forward to reviewing your qualifications and exploring the potential fit for this role. For more information about careers at Kimberly-Clark, visit our website. In conclusion, this role offers you the opportunity to be part of a team dedicated to innovation, growth, and impact. With a focus on sustainability, inclusion, and career development, Kimberly-Clark provides a supportive environment where you can make a meaningful difference in the world. Join us on this exciting journey of purpose-driven performance and growth.,

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2.0 - 5.0 years

0 Lacs

Bengaluru, Karnataka, India

Remote

Job Summary: We are seeking for a highly motivated Associate to join the Design Control team. The ideal candidate will have experience in Design Control and Risk Management of Medical Devices, proficiency with Teamcenter PLM or similar product lifecycle management tools and with Polarion or similar requirements management tools. This role will play an important role in transforming and uplifting Design History Files to Teamcenter PLM and maintaining DHF documentation in the PLM system. Key Responsibilities: Plan and execute the migration of Design History Files from the current systems to Teamcenter PLM. Develop and maintain Design Control and Risk Management documentation in the PLM system. Collaborate with cross-functional teams to ensure seamless implementation of Teamcenter PLM into the organization. Provide support and/or training to team members on the use of digitized tools and processes. Utilize Polarion requirements management tools to manage and track requirements. Ensure compliance with Design Control regulations and standards for medical devices. Identify and implement process improvements to enhance efficiency and compliance. Qualifications: Bachelors degree in engineering, or a related field. Minimum of 2 5 years of experience in Design Control of Medical Devices (e.g., electromechanical, optical, SiMD/SaMD, combination products). Proficiency with Teamcenter PLM or similar product lifecycle management tools. Preferred: Experience with Polarion or similar requirements management tools. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers. Detail-oriented with a commitment to quality and compliance. Knowledge, Skills And Abilities Personal Effectiveness Competencies: Project Excellence - Intermediate Continuous Learning - Intermediate Digital and Technology Savvy - Intermediate Operational Excellence - Intermediate Breakthrough Analysis - Intermediate Organizational Savvy - Fundamental Skills and Knowledge: Design Control and Risk Management STEAM Applied Science, Technology, Engineering, Arts and Math Regulations and Guidelines Proficiency with Teamcenter PLM or similar product lifecycle management tools Preferred: Polarion or similar requirements management tools Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio) Technical/Scientific Writing in English in a regulated environment Verbal English communication skill (in a remote environment) Preferred: Project Management experience Experiences Cross Functional collaboration - Primary New Product Innovation - Secondary Accountability - Primary Influencing without Authority - Primary Managing Crisis Secondary Functional Breadth - Secondary Licenses and Certifications ISO 13485 Training Preferred ISO 14971 Training Preferred IEC 62366 Training Preferred IEC 62304 Training Preferred Language Skills Fluent English; excellent verbal and written communication skills ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason. Show more Show less

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3.0 - 7.0 years

0 Lacs

tamil nadu

On-site

You will be responsible for Mechanical design in the field of Medical Devices, with a focus on Medical Device Design Controls, Design Verification, and Validation processes. A minimum of 3 to 5 years of relevant experience is required for this role. As a Sustaining Engineer, you will lead Change Qualification projects for medical devices, collaborating with a diverse Cross-Functional Team. Your tasks will include developing test protocols, ensuring the quality of deliverables, and managing risk through proactive identification and mitigation planning. Proficiency in DesignControl process for Medical Devices is essential, along with expertise in Mechanical Engineering basics. You should possess strong project management skills and the ability to work independently. Additionally, you must have excellent oral and written communication skills, with a particular emphasis on technical writing. Knowledge of ISO13485 standards is advantageous for this position. Proficiency in software tools such as SolidWorks, 2D design, Tolerance Stackup, and MS Word/Excel/PowerPoint is required. However, eligibility for the role is not solely based on software tool proficiency but also on your overall expertise and experience in the field. To apply for this role, you must hold a B.E/B.Tech or higher degree in Mechanical Engineering. Your role will involve collaborating with stakeholders to drive technical solutions and effectively communicate complex engineering concepts. You should be self-motivated, detail-oriented, and capable of applying statistical methods to problem-solving. The position is based in Chennai, and the walk-in interview is scheduled for 26th July at HCLTech Elcot Sez, Chennai. Interested candidates can send their CV to laveena.deenadayalan@hcltech.com with the subject line "Application for Design Verification Engineer - Chennai".,

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5.0 - 10.0 years

0 Lacs

karnataka

On-site

As a member of the Biocon Biologics team, you will be part of a company that is shaping the future of healthcare by prioritizing patients and aiming to impact a billion lives. Our focus on affordable innovation, patient centricity, and disruptive thinking drives us to deliver high quality biosimilars globally. We are a diverse, global company that values purpose and passion in our employees, who work together closely with partners and patients to bring innovative healthcare solutions to the market. Your role will involve leading the full lifecycle execution of medical device development programs, ensuring alignment with design control and regulatory standards. You will be responsible for managing program budgets, collaborating with internal and external stakeholders, overseeing project timelines, and identifying and mitigating risks. Additionally, you will facilitate partner interactions, review RFQs, maintain program dashboards, and champion continuous improvement in program governance and documentation. To excel in this role, you should have 8-10 years of experience in the medical device industry, with at least 5 years in project/program management, preferably in drug delivery systems. You should possess a strong understanding of design control, device development processes, and lifecycle management. Proficiency in tools like Microsoft Project, Excel, and PowerPoint is essential, along with experience working with global partners and cross-functional teams. Your behavioral and leadership skills will play a crucial role in your success, as you will need to effectively manage stakeholders, lead complex programs independently, and drive cross-functional alignment. A strategic mindset with attention to detail, risk assessment, and execution discipline will be key, along with a collaborative and adaptive approach to teamwork. Please note that this role is not suitable for IT professionals, as it does not involve core IT responsibilities.,

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3.0 - 8.0 years

0 Lacs

kanchipuram, tamil nadu

On-site

You will be responsible for mechanical design tasks related to industrial, construction, and Hydraulic Machinery. Your key duties will include designing mechanical structures for machinery, creating Bill of Materials for mechanical components, preparing manufacturing drawings & 3D modeling, designing fixturing and packing fixtures, coordinating with stakeholders for manufacturing, and demonstrating expertise in CAD tools. Proficiency in AutoCAD and CREO is mandatory. Additionally, you will be involved in benchmarking, competitor analysis, cost analysis, and value engineering to ensure high-quality design solutions. This role requires a Bachelor of Engineering (BE) degree and 3-8 years of relevant experience.,

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