16 Iec 60601 Jobs

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. Youll ensure full compliance with standards like IEC 60601, ISO 13485/14971, IEC 62366, and FDA 21 CFR 820. • Key Responsibilities End-to-End Electronics Design Drive schematic design and PCB layout from scratch using Altium Designer , including creation of symbols, footprints, library management, and templates. Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC, thermal performance, DRC/ERC, and DFM/DFT. Components & Libraries Build and maintain Altium library assets (schematics, PCB footprints, 3D models), and manage lifecycle with traceability for compliance. Medical-Grade Standards & Design Control Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820 processes. Support DFMEA/risk management and maintain complete Design History File (DHF). Prototype & Test Develop and execute test setups for verification/validation, including electrical safety, EMC, and performance benchmarks. Debug via oscilloscopes, spectrum analyzers, and logic analyzers through first builds and pilot runs. Cross-Functional Collaboration Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure seamless integration and production readiness. Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation handoff. Documentation & Leadership Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans, and validation reports. Lead schematic/PCB design reviews and mentor junior engineers. Required Skills & Experience Bachelors or Masters in Electronics/Electrical/Biomedical Engineering. 57 years in electronics design, ideally in medical-device or similarly regulated sectors. Proficiency in Altium Designer (schematic capture, multi-layer PCB layout, library and template creation). Solid knowledge of analog/digital circuit design, power distribution, sensor/MCU interfaces, high-speed considerations. Hands-on testing experience with oscilloscopes, logic analyzers, EMC analyzers. Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366, FDA 21 CFR 820. Excellent documentation skills, attention to detail, and teamwork orientation. Desired (Plus) Skills Experience in signal integrity, EMC/EMI mitigation, or high-speed board designs. Familiarity with embedded firmware collaboration or sensor-driven system design. DFMEA, obsolescence planning, and life-cycle management proficiency. Knowledge of RoHS, IPC standards, and medical usability engineering. Benefits Competitive compensation, performance bonuses Medical insurance and wellness initiatives Career growth, training, and certification support Collaborative global environment shaping medical-grade technology How to Apply Send your CV and cover letter detailing Altium-based schematic & PCB design experience in medical devices to career@innoiq.com with subject: Electronics Engineer Medical Device, Pune (Altium)

We are also Considering candidates Willing to Relocate - Job Location : Chennai Experience : 15 - 25 Years We are accepting Job Applications : Please submit updated CV - Email : [HIDDEN TEXT];[HIDDEN TEXT] Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure compliance with industry standards and best practices. - Interface with hardware engineers to define system requirements and specifications. - Develop and execute testing and validation plans for embedded software. - Stay updated with the latest advancements in embedded systems and incorporate relevant technologies. - Document software design and development processes. - Guide and provide necessary support for embedded software development according to medical device compliance and regulations(FDA, EU-MDR primarily). - Adaptive to manage and co-ordinate cross functional demand during product development and maintenance. Skills & Qualifications - Bachelor&aposs or Masters degree in Computer Science, Software Engineering, Electronics Engineering, or a related field. - Embedded architect experience primarily medical device. (High preference for hemodialysis machine and Renal care device experience) - Knowledge in IEC 62304, IEC 60601, ISO 13485 based embedded development. - Medical devices experience who can write SRS and run the entire product design process. - Over 12 years of experience in embedded software development and architecture. - Proficiency in Embedded firmware using embedded C, C++, and assembly languages. - Extensive experience with real-time operating systems (RTOS) and embedded Linux. - Strong knowledge of microcontroller/microprocessor architectures. - Experience with communication protocols such as CAN, I2C, SPI, UART, USB, etc. - Excellent problem-solving and debugging skills. - Proven track record of leading and managing engineering teams. - Strong communication and documentation skills. - Professional certifications in embedded systems or software architecture are a plus. Preferred Skills: - Experience with hardware design and schematic review. - Knowledge of modern software development methodologies (Agile, Scrum). - Familiarity with version control systems such as Git. - Understanding of safety-critical systems and compliance standards. Differentiators o Experience in New Product Development(NPD) of medical devices. o Strong experience in Renal Care o Usability Analysis Show more Show less

Job Title: Senior R&D Engineer Medical Devices Location: Mumbai, IND Employment type: Part-time Position Summary: We are seeking an experienced R&D Engineer Trainer with 10+ years in the medical device industry to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launch. Oversee product development lifecycle including concept generation, prototyping, design verification & validation, risk analysis, and design transfer to manufacturing. Ensure compliance with FDA, ISO 13485, MDR, IEC 60601, ISO 14971 and other applicable regulations and standards. Drive innovation by identifying new technologies, materials, and processes that enhance product performance and cost-effectiveness. Lead technical design reviews, root cause analysis, and continuous improvement initiatives. Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and Marketing to ensure successful product development and launch. Manage design documentation including Design History File (DHF), Design Inputs/Outputs, and Risk Management Files. Provide technical leadership and mentorship to junior engineers and project teams. Interface with clinicians, key opinion leaders (KOLs), and end-users to incorporate clinical feedback into design. Lead problem-solving initiatives for product performance, reliability, and usability. Stay updated with medical device industry trends, regulatory changes, and emerging technologies. Qualifications & Requirements: Bachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field . 10+ years of progressive experience in R&D within the medical device industry. Strong knowledge of medical device product development processes, including Design Control per 21 CFR Part 820. Proven track record of successfully launching medical devices into global markets. Expertise in CAD tools (SolidWorks/Creo/AutoCAD) , prototyping, and testing methods. Experience with risk management (ISO 14971), usability engineering (IEC 62366), and biocompatibility standards (ISO 10993) . Strong project management and leadership skills with experience in leading cross-functional teams. Excellent problem-solving, analytical, and communication skills. Experience with Class II and Class III medical devices preferred. Core Competencies: Innovation & Creativity in Medical Device Development Regulatory & Quality compliance mindset Leadership & Mentorship abilities Cross-functional Collaboration Strong Analytical and Technical problem-solving Strategic thinking with hands-on execution Show more Show less

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 .

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 Lead Mechanical Engineer is responsible for designing, developing, troubleshooting Beckman Coulter Diagnostics modules and applying life cycle management principles and upholding established design practices and quality processes throughout 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: Lead and manage sustaining engineering activities for existing electro-mechanical products, including root cause analysis, corrective actions, and continuous improvement initiatives. Drive innovation by designing and developing mechanical solutions to enhance performance, safety, reliability, and cost-effectiveness. Own and maintain the prototyping infrastructure with adherence to 5S standards. Oversee prototype development internally or through suppliers, and executing testing, verification, and validation. Ensure thorough documentation including CAD models, drawings, specifications, and test plans. Collaborate with global cross functional teams to resolve manufacturing and field issues. Provide technical support to stakeholders, mentor junior engineers, and manage multiple projects with minimal guidance. Adapt quickly to changes in project direction and ensure successful project execution through feasibility studies, risk assessments, and design reviews. The essential requirements of the job include: Bachelor's degree in mechanical engineering or a related field with 7-10 years of experience. Strong knowledge of mechanical design principles, materials, manufacturing processes, Rapid Prototyping and Proficiency in SolidWorks CAD software and simulation tools. Strong knowledge on lean principles, 5S, Kaizen and Proto build workshop management. Hands-on experience in building mechanical parts and assemblies using tools and machines. Skilled in teardown analysis, reverse engineering, and selection of off-the-shelf Electro-mechanical components. Thorough knowledge of vendor and supplier management for prototype builds, including managing quality and delivery timelines. Familiar with import/export processes documentation between India and other countries. Knowledge of should-costing, estimation, and dFMEA/pFMEA, DFX, Tolerance Stack-up Analysis and GD&T. Create and maintain detailed engineering documentation, including CAD models, drawings, specifications, test plans. Experience with medical device regulations (FDA, ISO 13485, ISO 14971, IEC 60601) and Ensure compliance with industry standards, regulations, and company policies. It would be a plus if you also possess previous experience in: Medical device design & development or IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular microbiology or flow cytometry systems is a plus Electro-Mechanical products, Robotics and Automation 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 .

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 .

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 .

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Regulatory Specialist Technical Writer to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medical devices (hardware and software), with a focus on ensuring compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and others. Note: - Apply only if you have experience in IEC 62304 ,IEC 62366, IEC 60601, ISO 14971. Key Responsibilities: Regulatory Documentation & Submissions. Prepare and maintain high-quality regulatory documentation including: Technical Files / Design Dossiers Clinical Evaluation Reports (CERs) Risk Management Files Declarations of Conformity FDA submissions (510(k) or pre-submissions, if applicable) Collaborate with cross-functional teams to gather inputs from R&D, QA, Clinical, and Marketing for submission documents. Technical Writing: Write, edit, and proofread SOPs, work instructions, user manuals, labeling, and IFUs to ensure technical accuracy and regulatory compliance. Translate complex technical data into clear, concise, and user-friendly documentation. Compliance & Standards: Stay current with regulatory changes (EU MDR, FDA, etc.) and update internal documentation and processes accordingly. Ensure documentation aligns with applicable standards such as: ISO 13485 ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) IEC 62366 IEC 60601 (Electrical Medical Devices) EU MDR 2017/745 FDA 21 CFR Part 820 Quality System Support: Support internal audits and inspections by maintaining complete and audit-ready documentation. Assist in CAPA documentation and post-market surveillance reports when required. Required Qualifications: Bachelors or masters degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. 25 years of experience in regulatory writing or regulatory affairs in a medical device or healthcare product environment. Strong knowledge of global medical device regulatory frameworks (FDA, EU MDR, etc.). Excellent written English and technical writing skills. Strong organizational and project management skills. Preferred Qualifications: Experience preparing 510(k), CE Mark, or similar submissions. Familiarity with digital pathology, imaging devices, or software as a medical device (SaMD). Certification in Regulatory Affairs (e.g., RAPS RAC) is a plus. Show more Show less

PRINCIPAL ENGINEER/ SENIOR TECHNICAL ARCHITECT Job Requirements We are seeking an experienced Embedded Software Architect to lead and oversee the design and development of embedded software systems. The ideal candidate will have over 15 years of experience in the field, with a strong background in C/C++ programming, real-time operating systems, and hardware-software integration. This role involves collaborating with cross-functional teams to deliver innovative and high-quality embedded solutions. Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure compliance with industry standards and best practices. - Interface with hardware engineers to define system requirements and specifications. - Develop and execute testing and validation plans for embedded software. - Stay updated with the latest advancements in embedded systems and incorporate relevant technologies. - Document software design and development processes. - Guide and provide necessary support for embedded software development according to medical device compliance and regulations. - Adaptive to managing and co-ordinate cross functional demand during product development and maintenance. Work Experience Required Skills: Bachelor's or masters degree in computer science, Software Engineering, Electronics Engineering, or a related field. - Embedded architect experience specifically in hemodialysis machine and Renal care device generally. - Medical devices experience who can write SRS and run the entire product design process. - Over 15 years of experience in embedded software development and architecture. - Proficiency in C, C++, and assembly languages. - Extensive experience with real-time operating systems (RTOS) and embedded Linux. - Strong knowledge of microcontroller/microprocessor architectures. - Experience with communication protocols such as I2C, SPI, UART, USB , etc. - Excellent problem-solving and debugging skills. - Proven track record of leading and managing engineering teams. - Strong communication and documentation skills. - Professional certifications in embedded systems or software architecture are a plus. Preferred Skills: - Experience with hardware design and schematic review. - Knowledge of modern software development methodologies (Agile, Scrum). - Familiarity with version control systems such as Git. - Understanding of safety-critical systems and compliance standards.

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train crossfunctional teams on standards, good documentation practices, and change control. Set up postmarket surveillance, complaint handling, and vigilance procedures ahead of launch. Preferred candidate profile Bachelors degree in engineering, Life Sciences, or related field; ISO13485 internalauditor certification preferred. 5 –10years’ QARA experience with ClassII (or higher) medical devices, ideally in a startup/smallteam environment. Demonstrated handson implementation of ISO13485 and compilation of CDSCO dossiers or FDA/CE submissions. Working knowledge of ISO14971, IEC62304, IEC60601, and Indian MDR2017; familiarity with EU MDR and 510(k) processes. Strong documentation skills, analytical mindset, and ability to translate regulatory language into actionable tasks for engineers. Selfstarter who thrives with minimal supervision and juggles multiple priorities in a fastmoving startup.

Responsibilities: * Collaborate with cross-functional teams on project requirements and deliverables. * Ensure compliance with IEC 60601 standards for medical devices. strong understanding of FPGA platforms AMD/Xilinx, Vivado, VHDL and RTL. Provident fund

PRINCIPAL ENGINEER/ SENIOR TECHNICAL ARCHITECT Job Requirements We are seeking an experienced Embedded Software Architect to lead and oversee the design and development of embedded software systems. The ideal candidate will have over 15 years of experience in the field, with a strong background in C/C++ programming, real-time operating systems, and hardware-software integration. This role involves collaborating with cross-functional teams to deliver innovative and high-quality embedded solutions. Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure compliance with industry standards and best practices. - Interface with hardware engineers to define system requirements and specifications. - Develop and execute testing and validation plans for embedded software. - Stay updated with the latest advancements in embedded systems and incorporate relevant technologies. - Document software design and development processes. - Guide and provide necessary support for embedded software development according to medical device compliance and regulations. - Adaptive to managing and co-ordinate cross functional demand during product development and maintenance. Work Experience Required Skills: Bachelor's or masters degree in computer science, Software Engineering, Electronics Engineering, or a related field. - Embedded architect experience specifically in hemodialysis machine and Renal care device generally. - Medical devices experience who can write SRS and run the entire product design process. - Over 15 years of experience in embedded software development and architecture. - Proficiency in C, C++, and assembly languages. - Extensive experience with real-time operating systems (RTOS) and embedded Linux. - Strong knowledge of microcontroller/microprocessor architectures. - Experience with communication protocols such as I2C, SPI, UART, USB , etc. - Excellent problem-solving and debugging skills. - Proven track record of leading and managing engineering teams. - Strong communication and documentation skills. - Professional certifications in embedded systems or software architecture are a plus. Preferred Skills: - Experience with hardware design and schematic review. - Knowledge of modern software development methodologies (Agile, Scrum). - Familiarity with version control systems such as Git. - Understanding of safety-critical systems and compliance standards.

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. Youll ensure full compliance with standards like IEC 60601, ISO 13485/14971, IEC 62366, and FDA 21 CFR 820. • Key Responsibilities End-to-End Electronics Design Drive schematic design and PCB layout from scratch using Altium Designer , including creation of symbols, footprints, library management, and templates. Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC, thermal performance, DRC/ERC, and DFM/DFT. Components & Libraries Build and maintain Altium library assets (schematics, PCB footprints, 3D models), and manage lifecycle with traceability for compliance. Medical-Grade Standards & Design Control Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820 processes. Support DFMEA/risk management and maintain complete Design History File (DHF). Prototype & Test Develop and execute test setups for verification/validation, including electrical safety, EMC, and performance benchmarks. Debug via oscilloscopes, spectrum analyzers, and logic analyzers through first builds and pilot runs. Cross-Functional Collaboration Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure seamless integration and production readiness. Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation handoff. Documentation & Leadership Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans, and validation reports. Lead schematic/PCB design reviews and mentor junior engineers. Required Skills & Experience Bachelors or Masters in Electronics/Electrical/Biomedical Engineering. 57 years in electronics design, ideally in medical-device or similarly regulated sectors. Proficiency in Altium Designer (schematic capture, multi-layer PCB layout, library and template creation). Solid knowledge of analog/digital circuit design, power distribution, sensor/MCU interfaces, high-speed considerations. Hands-on testing experience with oscilloscopes, logic analyzers, EMC analyzers. Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366, FDA 21 CFR 820. Excellent documentation skills, attention to detail, and teamwork orientation. Desired (Plus) Skills Experience in signal integrity, EMC/EMI mitigation, or high-speed board designs. Familiarity with embedded firmware collaboration or sensor-driven system design. DFMEA, obsolescence planning, and life-cycle management proficiency. Knowledge of RoHS, IPC standards, and medical usability engineering. Benefits Competitive compensation, performance bonuses Medical insurance and wellness initiatives Career growth, training, and certification support Collaborative global environment shaping medical-grade technology How to Apply Send your CV and cover letter detailing Altium-based schematic & PCB design experience in medical devices to career@innoiq.com with subject: Electronics Engineer Medical Device, Pune (Altium)

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard. Proficiency in interpreting, applying complex regulations, and preparing associated documentation. Excellent interpersonal communication and collaboration skills Bachelor s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system. proficiency with written English and with neutral English accent Preferred Qualifications/ Skills Strong technical knowledge Effective probing skills and analyzing / understanding skills

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard. Proficiency in interpreting, applying complex regulations, and preparing associated documentation. Excellent interpersonal communication and collaboration skills Bachelor s degree in engineering, Science or related area Minimum of 2 years of experience working with medical devices regulations and quality management system. proficiency with written English and with neutral English accent Preferred Qualifications/ Skills Strong technical knowledge Effective probing skills and analyzing / understanding skills

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile