8 Iec 60601 Jobs

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