5 Iec 62304 Jobs

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time Company Overview: InnoIQ Engineering , a subsidiary of B&W Engineering und Datensysteme GmbH, Germany , is a leading company specializing in the research, design, and development of innovative medical devices . With a strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking a passionate and detail-oriented Embedded Software Engineer to join our growing engineering team. You will play a critical role in the development of embedded software solutions for cutting-edge medical devices , ensuring compliance with regulatory standards and delivering high-quality products that positively impact patient care. Key Responsibilities: Design, develop, test, and maintain embedded software for medical devices Collaborate with cross-functional teams including electronics, mechanical, and system engineers Write efficient, reliable, and reusable code in C/C++ for embedded platforms Contribute to software architecture and system integration for real-time embedded systems Conduct software verification, validation, and unit testing in accordance with IEC 62304 Support design documentation and risk management activities per ISO 13485 and ISO 14971 Debug hardware/software integration issues using appropriate tools and methods Participate in design reviews, code reviews, and continuous improvement activities Required Qualifications: Bachelors or Masters degree in Electronics Engineering , Computer Engineering , Embedded Systems , or related field 2+ years of experience in embedded software development , preferably in the medical device domain Proficiency in C/C++ programming and real-time embedded systems Experience with microcontrollers , RTOS , and hardware-software interfacing Strong understanding of software development life cycle in regulated environments Knowledge of medical standards such as IEC 62304 , ISO 13485 , and ISO 14971 Good problem-solving skills and attention to detail Proficient in written and spoken English Preferred Qualifications: Experience with wireless communication protocols BLE, NFC Familiarity with version control systems Git and tools like Jira, Confluence Experience in developing software under Agile or V-model process Why Join Us? Be part of a global team developing life-enhancing medical technologies Work in a culture that values innovation , precision , and continuous learning Opportunities to grow in a fast-paced , quality-driven , and regulatory-compliant environment Exposure to international projects and collaboration with leading medical device companies

Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management. Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables. Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts. Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR. Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product launches. Strong background in Biomedical Instrumentation Engineering, coupled with hands-on experience in driving cross-functional collaboration, complaint resolution, and continuous improvement initiatives. Proficient at leading complaint investigations, conducting trend analysis, and maintaining high standards of product quality and safety across the development lifecycle. Experience in DHF Gap assessments and Remediation activities. Experience in Medical Device SotA standard gap assessment for EU MDR and 510k projects. Implemented and Maintained quality systems according to ISO 13485:2016 and ISO 9001:2015. Performed Internal Quality Audits according to ISO 13485:2016 and ISO 9001:2015. Should Performed risk assessments according to ISO 14971:2019. Experience in Planning software verification and validation activities by identifying test requirements. Should have Worked on Technical documents like Trace matrix, STED, Design inputs, LRS. Should Perform Gap assessments and remediation activities for IEC 60601-1 series, IEC 62304, IEC 62366-1, ISO 11607-1, ISO 11607-2 and other medical device standards. Have knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Hands on experience in labeling activities based on ISO 20417 and ISO 15223-1.

System Engineer /Sr. Systems Engineer Location: Pune, India Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH, Germany) Industry: Medical Devices / Engineering Services Employment Type: Full-time Role Summary: We are seeking a meticulous and detail-oriented System Engineer to join our growing team. In this role, you will be responsible for translating product needs into clear, structured, and testable requirements and specifications that guide engineering teams through the development of medical devices. You will act as a critical bridge between product management, design, and engineering teams, ensuring that all stakeholder needs are accurately captured and documented. About Us: At InnoIQ Engineering , a proud subsidiary of B&W Engineering und Datensysteme GmbH, Germany , we specialize in the research, design, and development of innovative medical devices . Guided by German engineering principles and a deep understanding of global healthcare needs, we deliver precision, quality, and customer-centric solutions . From early concept to production support, we serve as a strategic engineering partner to leading medical technology companies. TitleSystem Engineer /Sr. Systems EngineerQualification Bachelors or masters degree in Biomedical/ Electronics/Electronics & Telecommunication/Computer/Mechatronics Engineering Expected Experience 5-10 Years of Relevant Experience with minimum 3 years in medical device or other regulated industry Experience in New Product Development (NPD)/New product Introduction and Sustenance Engineering is a must Job Responsibilities Derives requirements from high -level requirements into product level requirements. Develop clear, concise, and testable specifications for hardware and software components of medical devices. Collaborates with multiple teams including client team, marketing/business development teams, technical teams, quality and regulatory teams to decompose needs statements into system product level requirements for medical devices and accessories Maintain traceability matrices and ensure alignment with verification and validation plans Participates in design reviews, including reviews of design inputs and outputs to ensure requirements are feasible and aligned with product goals. Keeps abreast of new developments in all relevant technological domains Envision, Desing, Build innovative solutions for customer Needs, Product & Services Ideation and conceptualization. POC development and prototyping Actively participates in design fraternity by sharing and learning best practices and gets involved in other organization initiatives Required Skills In-depth understanding of both hardware and software for integrated products Experience with tools such as DOORS, Jama, Polarion, or equivalent is a plus. Experience with embedded microprocessors and microcontrollers Experience with Product Design Hands on with ADC/DAC/Chemical Sensors Knowledge of IOT, Bluetooth, Wi-Fi, USB, File System for Embedded Platform Knowledge of global quality and regulatory environment for Medical devices including , FDA, EU MDR, MDD, IEC 60601-1-1(CE marking), ISO 13485, IEC 62304, ISO 14971 Strong understanding of Safety risk management, including FMEA, design mitigations, and risk management standards Strong Customer facing skills Effective verbal/written communication, documentation, presentation and interpersonal skills, as well as the ability to work both independently and as part of team Desirable Skills Firmware Experience with RTOS or Baremetal System level Circuit Modeling with EDA tools(or similar). SPICE Design of experiment (DOE) methodologies Design for excellence viz DFM, DFT, DFR Usability aspects of Medical devices according to HFE/HE75. IEC 62366, IEC 60601-1-6 etc What We Offer: Opportunity to work on cutting-edge medical technologies. Involvement in meaningful projects that directly impact patient care and quality of life A collaborative and innovation-driven work culture. Exposure to international projects and clients. Professional development and training programs. Flexible working hours / Hybrid work / International team / Training programs, etc Competitive compensation and benefits.

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management Skills : - Cypress, API automation, Appium, TestNG, Jenkins, JIRA, JAMA, GIT, SaaS applications, HIPAA, ISO 13485, IEC 62304, software testing, medical device testing, test automation, defect tracking, agile methodology

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management