8 Iec 62304 Jobs

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

Role: Strong Medical Device Embedded Firmware Experience with RTOS. Embedded Software Engineers with focus on Field-Reported issue resolution Background: The customer has a long-term initiative of product complaint handling, which has the objective to drive and investigate hard-to-find microcontroller-based embedded software anomalies, e.g., race conditions, runtime conflicts, task priority issues, and configuration issues. Key Job Responsibilities Continuous testing and proactively identifying/simulating anomalies that may impact device functionality, performance, and safety. Root Cause analysis of the issue through analysing code, Embedded software architecture, system hardware integration, state diagrams, etc. Embedded SW change impact assessment (System & Performance) Debugging, and fixing issues in Embedded Software C/C++ source code, running on RTO and Microcontroller hardware Defect cycle management, change management and Emb SW release management Updating Software documents, Risk analysis Key Skills : Experience Required—4 to 8 year experience of Embedded Firmware Development Medical Device Embedded Firmware development experience—5+ years Experience in reproducing complex , hard-to-find system issues and their root cause analysis. Architectural/Design Trade-offs—Safety and Availability Knowledge and Experience of SDLC as per IEC 62304 Software Development documentation—SRS, SDS, Architecture, Software Risk Management, Software Verification Implementation of Safety Control Measures in Embedded Software Experience of Working on embedded Linux and C/C++ Application development Working with microcontrollers & hardware debug—UART, SPI, I2C Interfaces, Memory management, USB/Bluetooth/Wi-Fi interfaces, IO handling Ability to think over border aspects of product, be creative in solving challenging problems Experience of using software analysis tools—IDE, Static Code analysis

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

Location: Pune, India Work Mode: Hybrid Experience: 14-17 Years Role: Full-Time / Permanent About the Role: We are seeking a Senior Software Engineer (P5) to design, develop, and test software applications for medical software products . You will play a critical role in building innovative solutions for implantable medical device systems, ensuring compliance with regulatory standards while driving cutting-edge development. Key Responsibilities: Develop and test C#/.NET applications using WPF, UWP, SOA, and Entity Framework . Lead the end-to-end software development lifecycle , from requirements to deployment. Ensure compliance with medical device regulations (21 CFR Part 820, IEC 62304, ISO 13485). Implement best practices in software architecture, design, and code reviews . Utilize tools like Git (source control), Jira (issue tracking), Cockpit (requirements management), and Code Collaborator (code review) . Provide technical leadership and mentor a team of engineers. Collaborate cross-functionally with R&D, Quality, and Product teams to drive innovation. Required Skills & Experience: 14-17 years of experience in software development. Proficiency in C#/.NET, WPF, UWP, SOA, Entity Framework . Strong experience in Agile development and object-oriented design (OOD) . Knowledge of medical device software regulations (21 CFR Part 820, IEC 62304, ISO 13485). Hands-on experience with Git, Jira, Cockpit, and Code Collaborator . Strong communication, problem-solving, and leadership skills. Preferred Qualifications: Experience with Brainlab Surgical Planning Software . Familiarity with cloud technologies and microservices is a plus.

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

5+ years of experience in the development and advancement of quality management and quality improvement measures, ideally in the field of medical software Submit your resume and cover letter to hr@squarematrixtechnologies.in .

Extensive Testing Experience: At least 10 years of experience in electronic testing, with a minimum of 2-3 years in a managerial role. In-depth knowledge of testing methodologies, tools, and techniques.