We are seeking a skilled and proactive Medical Device Cybersecurity Engineer to join our team. This position plays a critical role in ensuring the cybersecurity and regulatory compliance of our connected medical devices throughout the product lifecycle. The ideal candidate has hands-on experience in threat modeling, managing third-party software components, performing vulnerability scans and penetration testing, and collaborating across cross-functional teams to integrate robust cybersecurity controls in accordance with FDA and global regulatory requirements. Key Responsibilities: Perform and maintain comprehensive threat modeling (e.g., STRIDE) for embedded and connected medical devices. Perform regular vulnerability scans, penetration testing , and static/dynamic analysis using tools such as Kali Linux, Metasploit, Wireshark, NMAP, Fortify, Nessus, or similar. Develop and update cybersecurity risk assessments as part of the overall risk management process (including CVSS scoring). Define, implement, and document security controls based on threat model outcomes. Manage and maintain Software Bill of Materials (SBOM) in compliance with FDA premarket and post-market guidance and global standards (e.g., NTIA, NIST). Support secure software development lifecycle (SDLC) practices including secure coding reviews. Conduct cybersecurity surveillance for new threats, advisories, CVEs, and zero-day vulnerabilities that may impact devices post-market. Triage and assess reported vulnerabilities, coordinate remediation and update documentation accordingly. Support preparation of cybersecurity documentation for FDA submissions (e.g., premarket submissions, 510(k), PMA) including security risk management reports and architecture diagrams. Ensure compliance with FDA applicable standards (e.g., ISO 14971, IEC 62304, ANSI/AAMI SW96:2023) Collaborate with Quality, Regulatory, and Engineering to ensure cybersecurity is integrated across the product lifecycle. Collaborate with software, hardware, and systems teams to guide cybersecurity design and testing. Qualifications Required: Bachelors or Masters degree in Computer Engineering, Cybersecurity, Electrical Engineering, or related field. 57 years of experience in embedded systems or medical device cybersecurity. Strong working knowledge of SBOM, SOUP, vulnerability scanning tools, penetration testing, and threat modeling methodologies. Familiarity with relevant regulations and standards (e.g., FDA Cybersecurity Guidance, NIST SP 800-53/30/218, ANSI/AAMI SW96:2023). Experience with secure development tools and CI/CD environments. Preferred: Certified Ethical Hacker (CEH), CISSP, CSSLP, or similar certification. Experience with connected devices (IoMT), wireless protocols (BLE, Wi-Fi), and cloud security principles. Familiarity with DevSecOps practices and security tools integration.
Job Description: We are seeking a highly skilled and proactive Electrical Engineer to join our team in designing, developing, and testing embedded and medical electronic products. The ideal candidate should have extensive experience in Circuit Design & PCB Design using Altium, Board Bring up, Troubleshooting Electrical/Electronic designs. Responsibilities Design and develop analog, digital, and mixed-signal circuits for embedded systems. Develop microcontroller-based hardware using interfaces such as I2C, SPI, UART, USB, and ADCs. Design power supply and battery-powered systems, including DC-DC converters. Interface sensors with microcontrollers for medical/embedded applications. Create schematics and multi-layer PCB layouts using Altium Designer or equivalent tools. Perform board bring-up, validation, and debugging using lab equipment (oscilloscope, multimeter, power supply, etc.). Develop and execute test plans in alignment with design requirements and product specifications. Contribute to hardware architecture decisions and component selection. Maintain design documentation, BOMs, Gerber files, and revision control. Support DFM/DFA reviews and collaborate with manufacturing vendors to ensure scalable, reliable builds. Qualifications Experience designing electronics for medical devices or regulated industries. Knowledge of high-speed PCB layout, signal integrity, EMI/EMC, and impedance control. Exposure to product development processes including DFMEA, V&V, ISO 14971 risk management, and QMS documentation. Familiarity with tools like Git, Jira, TestRail, Confluence, Helix/TestTrack. Experience with component obsolescence management and hardware reliability techniques. Understanding of design automation, test fixture design, and hardware test scripting. Soft Skills Strong analytical and problem-solving ability. Ability to communicate technical ideas clearly across teams. Organized, self-driven, and adaptable in a fast-paced environment.
We are seeking a skilled and hands-on Embedded Systems Architect to lead the design and development of embedded hardware and firmware systems, spanning microcontroller and microprocessor-based solutions. The ideal candidate will have at least 10 years of experience in embedded systems development, particularly in medical devices or other highly regulated industries. This role will be instrumental in designing high-reliability embedded architectures, ensuring compliance with medical device standards (IEC 62304, ISO 13485, FDA 21 CFR Part 820), and guiding development teams through full product lifecycles. Responsibilities: Architect and oversee development of embedded systems that use 32-bit microcontrollers (STM32, NXP, TI) and application processors (ARM Cortex-A, i.MX, etc.). Drive the complete product life-cycleconcept, requirements capture, architecture, design, implementation, verification, release, and long-term maintenance. Collaborate with hardware, software, quality, and regulatory teams to translate product requirements and constraints into robust system architectures. Lead firmware development in C and C++ for bare-metal, RTOS, and embedded-Linux targets, including board support packages, bootloaders, and secure update mechanisms. Define board-level hardware architecture—power, sensing, and communication subsystems (UART, SPI, IC, CAN, USB, BLE, Wi-Fi, cellular)—in partnership with hardware engineers. Perform system bring-up, low-level debugging, and integration of BSPs, device drivers, and middleware. Ensure compliance with FDA regulations, ISO 13485, IEC 62304, and cybersecurity guidance (AAMI TIR57, FDA Premarket Cybersecurity). Lead risk-management activities, including hazard analysis, FMEA, and verification / validation planning and execution. Evaluate and recommend embedded platforms, SoCs, and communication protocols that best meet technical, cost, and schedule objectives. Conduct design and code reviews, establish best practices, and mentor junior engineers. Produce and maintain high-quality documentation: system architecture specifications, design rationales, test protocols, and risk analyses. Qualifications: 10+ years of hands-on experience in embedded systems development, preferably in regulated industries such as medical devices, aerospace, automotive, or industrial safety. Proficient in C and C++ for real-time, safety-critical, and low-level systems. Deep expertise in embedded Linux development, including Yocto, Buildroot, kernel customization, and driver integration. Strong experience with RTOS (e.g., FreeRTOS, Zephyr, QNX) and bare-metal firmware. Proven background in technical consulting or client-facing product development roles. Solid understanding of ARM Cortex-M/A architectures, embedded security, and peripheral interfaces. Skilled in using debugging and diagnostic tools such as oscilloscopes, logic analyzers, and JTAG/SWD debuggers. Familiar with relevant standards and regulatory frameworks, including IEC 62304, ISO 14971, and FDA software validation. Experience with wireless protocols (BLE, Wi-Fi, LoRa) and embedded cybersecurity practices. Excellent leadership, communication, and documentation skills. Strong problem-solving mindset and collaborative approach to innovation. What We Offer: Competitive salary and comprehensive benefits package. A collaborative work environment that values innovation and growth. Opportunities for professional development and career advancement. The chance to contribute to life-changing medical device solutions.
Biovantage employs a lean and efficient team wherein each capable member is involved in inter-disciplinary work, which develops their talent in business areas that go beyond technical know-how. Therefore, while as a Full Stack Developer, you will primarily be responsible for designing, developing, and maintaining the front-end and back-end components of our web applications, you will also work closely with our product, design and engineering teams to deliver high-quality software to clients, and with our management to design and implement novel business ideas and ventures. Position: Full Stack Developer Skills: 2+ years of professional experience in full stack development. Proficiency in front-end technologies: HTML, CSS, JavaScript, and modern frameworks/libraries such as React.js (Specifically Next.js) for the frontend and C#, ASP .NET framework. Strong back-end development skills using languages such as C#, Node.js (JavaScript/TypeScript), Python, or PHP. Experience with database management systems, particularly PostgreSQL. Familiarity with RESTful APIs and web services architecture. Knowledge of version control systems, particularly Git. Experience with cloud platforms such as AWS, Azure, and knowledge of their services offered is a plus. Experience with AI agents and building custom agents. Responsibilities: Develop and maintain web applications using modern front-end and back-end technologies. Collaborate with cross-functional teams to define, design, and ship new features. Write clean, maintainable, and efficient code. Optimize applications for maximum speed and scalability. Troubleshoot and debug issues and perform code reviews. Implement responsive web design principles to ensure our applications work well across various devices and screen sizes. Negotiate and communicate effectively with the clientele. Breakdown requirements into modular tasks and create timelines Stay up to date with emerging technologies and industry trends. Mentor junior developers and contribute to a culture of continuous improvement. Preferred: Experience with CI/CD pipelines and DevOps practices. Understanding of containerization and orchestration tools like Docker and Kubernetes. Knowledge of microservices architecture. Familiarity with Agile/Scrum methodologies. Ability to work independently and manage multiple tasks effectively. Interest in client-facing opportunities Interest in learning novel technologies and working simultaneously with multiple tech-stacks. Strong problem-solving skills and attention to detail. Qualification: Bachelor's or master's degree in information technology, Computer Science or other relevant technical discipline.
We are currently seeking a talented Senior Verification & Validation Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry. Job Title: Senior Verification & Validation. Experience: 5 - 10 Years Qualification: B.E/B.Tech or equivalent degree in Computer Science / Information Technology. Job Description: Biovantage is looking for a qualified Senior Verification & Validation Engineer to perform end to end software verification and validation for our various Medical Device and Software as a Medical Device product development projects. As a Senior V&V Engineer, you will be actively involved in understanding / authoring the software requirements, developing test protocols, executing test cases, and automating those test cases. You will continuously track software bugs and control the overall quality of the software. Required Skills: Experience in software testing and automation for Embedded Software, Web Applications & Mobile Applications. Excellent aptitude and reasoning with understanding of Software QA methodologies, tools, and processes. Experience in development, execution and review of software verification plan, test methods, test strategies, acceptance criteria, test cases, test reports, and traceability reports. Experience working in an ISO 13485 compliant environment. Strong problem-solving skills to participate in troubleshooting of issues with different teams to drive towards root cause identification and resolution. Good team player with excellent communication skills, to be able to collaborate and work with cross functional teams. Ability to work in a fast-paced, dynamic work environment with a focus on technical excellence, responsiveness to meet timelines. Ability to work on multiple projects in a deadline driven environment. Preferred Skills: Experience in software testing for medical domain products. Experience in building test automation framework. Familiarity with Requirements management tools, configuration management tools and test management tools like Git, TestRail, Jira, Helix/TestTrack, Confluence, etc. Experience with software and system risk analysis (per ISO 14971) including fault tree analysis, software failure mode and effects analysis (FMEA). Experience with FDA Guidance for Cybersecurity in Medical devices including threat modelling techniques and security risk management. Responsibilities: Responsible for the verification and validation of a medical software, including but not limited to development of software verification plan, review of system and subsystem requirements, design test strategies and methods, write and execute test cases, generate traceability reports, generate test execution reports. Identify / build test automation tools and framework, automate test cases. Collaborate with Product development teams to understand the product specification, system interfaces, operational requirements, performance requirements, software requirements, software design, etc. to discuss and review test methods and test strategies. Participate in review meetings with cross functional teams and contribute to writing software requirements, developing software verification protocol, etc. Teach and mentor fellow engineers, and work to foster an environment of development and inclusivity.
As a Software Architect you will primarily be responsible for architecting and overseeing the design of our cloud-based systems and taking the lead in tackling complex problems across projects. You will also work closely with our product, design, and engineering teams to deliver high-quality, scalable cloud solutions to clients, and with our management to design and implement novel ideas that merge efficient infrastructure design with profitable business initiatives. Position: Software Architect Responsibilities: 1. Architect, design, and document end-to-end cloud solutions on Microsoft Azure. 2. Lead technical design reviews, establish architecture patterns, and enforce best practices across the stack. 3. Optimize development workflow and integrate AI technology meaningfully to enhance productivity significantly. 4. Collaborate with product management and engineering teams to translate business requirements into scalable, reliable system designs. 5. Provide accurate work-effort estimates and technical risk assessments for new features and system enhancements. 6. Define and implement Infrastructure as Code (IaC) and manage CI/CD pipelines for automated, repeatable deployments. 7. Guide the selection and adoption of emerging technologies and AI-assisted development tools to enhance team productivity. 8. Mentor and coach engineering teams; conduct architecture workshops and knowledge-sharing sessions. 9. Drive performance tuning, capacity planning, cost optimization, and security/compliance reviews. 10. Troubleshoot and resolve high-severity production incidents; perform post-mortem analysis and implement corrective actions. Skills: 1. 10+ years of professional experience in software engineering and architecture. 2. Proven expertise in Microsoft Azure services. 3. Proficiency in front-end technologies: React.js, React Native, Next.js 4. Strong back-end development skills using C# (.NET Core). 5. Strong experience with database management systems, especially PostgreSQL. 6. Strong Experience in CI/CD platforms, including Azure DevOps. 7. Solid understanding of microservices architecture, event-driven design patterns, RESTful and gRPC APIs. 8. Familiarity with containerization and orchestration tools like Docker and Kubernetes (AKS). 9. Experience with AI-driven development assistants (e.g., GitHub Copilot). 10. Knowledge of DevSecOps practices, security frameworks (OWASP, CIS Benchmarks), and compliance standards (ISO 13485, SOC 2). Good to have: 1. Masters degree in Computer Science, or relevant field. 2. Experience with IoT, firmware communication (Bluetooth, WiFi, Serial), and associated protocols. 3. Experience with Cybersecurity Procedures: Vulnerability Assessment, Static Code Analysis, Penetration Testing, etc. 4. Azure Solutions Architect Expert or equivalent certification. 5. Experience with CI/CD pipelines and DevOps practices. 6. Experience with Sprint Boot (Java) and very good understanding of it. 7. Understanding of containerization and orchestration tools like Docker and Kubernetes. 8. Knowledge of microservices architecture and event-driven design patterns. 9. Familiarity with DevSecOps practices, security frameworks, and compliance standards. 10. Background in regulated industries (healthcare, medical devices, financial services). 11. Familiarity with Agile/Scrum methodologies. 12. Ability to work independently and manage multiple tasks effectively. 13. Interest in client-facing opportunities. 14. Interest in emerging technologies and multiple tech-stacks. 15. Strong problem-solving skills and attention to detail. Qualification: Batchelor's degree in Computer Science, Software Engineering, or other relevant technical discipline
Job Summary We are seeking a dynamic and experienced Human Resources Manager. The ideal candidate will manage core HR responsibilities while also ensuring smooth day-to-day office operations. This is a key position for someone who thrives in a hands-on, fast-paced environment and can balance people leadership with administrative excellence. Human Resources Management Responsibilities: Develop and implement HR strategies, policies, and processes aligned with business goals and legal compliance. Manage the full recruitment lifecycle including job descriptions, sourcing, screening, interviews, offers, and onboarding. Design and run employee onboarding, induction, and exit processes. Build and maintain accurate employee records and ensure data compliance. Oversee employee performance management systems and facilitate goal-setting, reviews, and feedback sessions. Identify training needs and coordinate learning and development programs in collaboration with department leads. Lead employee engagement initiatives including surveys, team-building activities, events, and recognition programs. Manage payroll inputs, compensation reviews, leave and attendance tracking, and benefits administration. Ensure compliance with Indian labor laws and statutory requirements (PF, ESI, Shops & Establishment, etc.). Address employee grievances, conflicts, and disciplinary matters with professionalism and confidentiality. Handle employee grievances and disciplinary procedures professionally and empathetically. Office Management Responsibilities: Coordinate with the companys external accountant and internal finance team to ensure timely salary disbursement, reimbursements, and compliance filings. Liaise with the company secretary for statutory filings, compliance, documentation, and board-related activities. Ensure regular maintenance and servicing of office equipment and infrastructure, including AMC contracts for ACs, pest control, water dispensers, printers, and other facilities. Oversee procurement and vendor management for office supplies, housekeeping, internet, courier, and IT support. Support internal teams (finance, procurement, IT, admin) with documentation, logistics, and operational coordination. Handle travel and accommodation logistics for employees and visitors. Monitor office expenses, ensure accurate documentation, and support timely payments through coordination with finance. Ensure cleanliness, hygiene, safety, and adherence to fire and security protocols within the office. Key Requirements: Bachelor's degree in Human Resources, Business Administration, or related field (MBA/PGDM in HR preferred). Minimum 5 years of total experience in Human Resources. Strong understanding of Indian labour laws, HR compliance, and performance management. Proficiency in HR software (Zoho People), Microsoft Office (Excel, Word, Outlook), and payroll tools (Zoho Payroll). Exceptional organizational and communication skills, with a proactive and problem-solving approach. Ability to maintain confidentiality and exercise sound judgment.
We are seeking a skilled and hands-on Embedded Systems Architect to lead the design and development of embedded hardware and firmware systems, spanning microcontroller and microprocessor-based solutions. The ideal candidate will have at least 10 years of experience in embedded systems development, particularly in medical devices or other highly regulated industries. This role will be instrumental in designing high-reliability embedded architectures, ensuring compliance with medical device standards (IEC 62304, ISO 13485, FDA 21 CFR Part 820), and guiding development teams through full product lifecycles. Responsibilities: Architect and oversee development of embedded systems that use 32-bit microcontrollers (STM32, NXP, TI) and application processors (ARM Cortex-A, i.MX, etc.). Drive the complete product life-cycleconcept, requirements capture, architecture, design, implementation, verification, release, and long-term maintenance. Collaborate with hardware, software, quality, and regulatory teams to translate product requirements and constraints into robust system architectures. Lead firmware development in C and C++ for bare-metal, RTOS, and embedded-Linux targets, including board support packages, bootloaders, and secure update mechanisms. Define board-level hardware architecturepower, sensing, and communication subsystems (UART, SPI, IC, CAN, USB, BLE, Wi-Fi, cellular)—in partnership with hardware engineers. Perform system bring-up, low-level debugging, and integration of BSPs, device drivers, and middleware. Ensure compliance with FDA regulations, ISO 13485, IEC 62304, and cybersecurity guidance (AAMI TIR57, FDA Premarket Cybersecurity). Lead risk-management activities, including hazard analysis, FMEA, and verification / validation planning and execution. Evaluate and recommend embedded platforms, SoCs, and communication protocols that best meet technical, cost, and schedule objectives. Conduct design and code reviews, establish best practices, and mentor junior engineers. Produce and maintain high-quality documentation: system architecture specifications, design rationales, test protocols, and risk analyses. Qualifications: 10+ years of hands-on experience in embedded systems development, preferably in regulated industries such as medical devices, aerospace, automotive, or industrial safety. Proficient in C and C++ for real-time, safety-critical, and low-level systems. Deep expertise in embedded Linux development, including Yocto, Buildroot, kernel customization, and driver integration. Strong experience with RTOS (e.g., FreeRTOS, Zephyr, QNX) and bare-metal firmware. Proven background in technical consulting or client-facing product development roles. Solid understanding of ARM Cortex-M/A architectures, embedded security, and peripheral interfaces. Skilled in using debugging and diagnostic tools such as oscilloscopes, logic analyzers, and JTAG/SWD debuggers. Familiar with relevant standards and regulatory frameworks, including IEC 62304, ISO 14971, and FDA software validation. Experience with wireless protocols (BLE, Wi-Fi, LoRa) and embedded cybersecurity practices. Excellent leadership, communication, and documentation skills. Strong problem-solving mindset and collaborative approach to innovation. What We Offer: Competitive salary and comprehensive benefits package. A collaborative work environment that values innovation and growth. Opportunities for professional development and career advancement. The chance to contribute to life-changing medical device solutions.
As a Senior Software Engineer, you will primarily be responsible for devloping reliable and robust software, architecting and overseeing the design of our cloud-based systems, taking the lead in tackling complex problems across projects, and ensuring compliance with coding standards. You will also work closely with our product, design, and engineering teams to deliver high-quality, scalable cloud solutions to clients, and with our management to design and implement novel ideas that merge efficient infrastructure design with profitable business initiatives. Position: Senior Software Engineer Responsibilities: Develop robust and reliable software solutions Architect, design, and document end-to-end cloud solutions on Microsoft Azure. Lead technical design reviews, establish architecture patterns, and enforce best practices across the stack. Collaborate with product management and engineering teams to translate business requirements into scalable, reliable system designs. Provide accurate work-effort estimates and technical risk assessments for new features and system enhancements. Define and implement Infrastructure as Code (IaC) and manage CI/CD pipelines for automated, repeatable deployments. Guide the selection and adoption of emerging technologies and AI-assisted development tools to enhance team productivity. Mentor and coach engineering teams; conduct architecture workshops and knowledge-sharing sessions. Drive performance tuning, capacity planning, cost optimization, and security/compliance reviews. Troubleshoot and resolve high-severity production incidents; perform post-mortem analysis and implement corrective actions. Skills: 7-12 years of professional experience in software engineering and architecture. Proven expertise in Microsoft Azure services. Proficiency in front-end technologies: React.js, React Native, Next.js Strong back-end development skills using C# (.NET Core). Strong experience with database management systems, especially PostgreSQL. Experience with IoT, firmware communication (Bluetooth, WiFi, Serial), and associated protocols. Solid understanding of microservices architecture, event-driven design patterns, RESTful APIs. Good to have: Masters degree in Computer Science, or relevant field. Experience with Cybersecurity Procedures: Vulnerability Assessment, Static Code Analysis, Penetration Testing, etc. Azure Solutions Architect Expert or equivalent certification. Strong Experience in CI/CD platforms, including Azure DevOps. Understanding of containerization and orchestration tools like Docker and Kubernetes. Knowledge of microservices architecture and event-driven design patterns. Background in regulated industries (healthcare, medical devices, financial services). Familiarity with Agile/Scrum methodologies. Ability to work independently and manage multiple tasks effectively. Interest in client-facing opportunities. Interest in emerging technologies and multiple tech-stacks. Strong problem-solving skills and attention to detail. Familiarity with containerization and orchestration tools like Docker and Kubernetes (AKS). Knowledge of DevSecOps practices, security frameworks (OWASP, CIS Benchmarks), and compliance standards (ISO 13485, SOC 2). Experience with AI-driven development assistants (e.g., GitHub Copilot). Qualification: Batchelor's degree in Computer Science, Software Engineering, or other relevant technical discipline
We are currently seeking a talented Senior Verification & Validation Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry. Job Title: Senior Verification & Validation Engineer Experience: 5 - 10 Years Qualification: B.E/B.Tech or equivalent degree in Electronics Engineering / Computer Science. Job Description: Biovantage is looking for a qualified Senior Verification & Validation Engineer to perform end to end software verification and validation for our various Medical Device and Software as a Medical Device product development projects. As a Senior V&V Engineer, you will be actively involved in understanding / authoring the software requirements, developing test protocols, executing test cases, and automating those test cases. You will continuously track software bugs and control the overall quality of the software. Required Skills: Experience in software testing and automation for Embedded Software, Web Applications & Mobile Applications. Excellent aptitude and reasoning with understanding of Software QA methodologies, tools, and processes. Experience in development, execution and review of software verification plan, test methods, test strategies, acceptance criteria, test cases, test reports, and traceability reports. Experience working in an ISO 13485 compliant environment. Strong problem-solving skills to participate in troubleshooting of issues with different teams to drive towards root cause identification and resolution. Good team player with excellent communication skills, to be able to collaborate and work with cross functional teams. Ability to work in a fast-paced, dynamic work environment with a focus on technical excellence, responsiveness to meet timelines. Ability to work on multiple projects in a deadline driven environment. Preferred Skills: Experience in software testing for medical domain products. Experience in building test automation framework. Familiarity with Requirements management tools, configuration management tools and test management tools like Git, TestRail, Jira, Helix/TestTrack, Confluence, etc. Experience with software and system risk analysis (per ISO 14971) including fault tree analysis, software failure mode and effects analysis (FMEA). Experience with FDA Guidance for Cybersecurity in Medical devices including threat modelling techniques and security risk management. Responsibilities: Responsible for the verification and validation of a medical software, including but not limited to development of software verification plan, review of system and subsystem requirements, design test strategies and methods, write and execute test cases, generate traceability reports, generate test execution reports. Identify / build test automation tools and framework, automate test cases. Collaborate with Product development teams to understand the product specification, system interfaces, operational requirements, performance requirements, software requirements, software design, etc. to discuss and review test methods and test strategies. Participate in review meetings with cross functional teams and contribute to writing software requirements, developing software verification protocol, etc. Teach and mentor fellow engineers, and work to foster an environment of development and inclusivity.
We are currently seeking a talented Lead Software Quality Assurance Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry. Job Title: Manager QA. Experience: 1015 years in Quality Assurance, with at least 5 years in a leadership or managerial role in the medical device industry. Qualification: Bachelor’s or master’s degree in engineering, Life Sciences, Quality Management, or related field. Certifications such as Internal/Lead Auditor ISO 13485, CQA (Certified Quality Auditor) Job Description: We are seeking an experienced and dynamic QA Manager to lead our Quality Assurance team and ensure compliance with regulatory and quality standards in the design, development, and manufacturing of medical devices. The QA Manager will be responsible for implementing and maintaining an effective Quality Management System (QMS), driving continuous improvement, and supporting cross-functional teams to achieve high-quality products aligned with global regulatory requirements. Responsibilities Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations . Lead internal and external audits, including FDA, ISO, notified body, and customer audits. Ensure effective CAPA, NCR, change control, and deviation management processes . Oversee document control, records management, and quality assurance reviews. Establish and monitor quality objectives, KPIs, and continuous improvement initiatives . Manage supplier quality audits, vendor qualifications, and incoming inspection processes . Collaborate with R&D, Regulatory, Manufacturing, and V&V teams to ensure compliance during product development lifecycle and design transfer . Train, mentor, and lead the QA team to strengthen organizational quality culture. Ensure effective risk management in accordance with ISO 14971 . Drive initiatives for process validation, software validation, and equipment qualification . Provide management with regular updates on quality system performance and improvement opportunities. Required Skills: Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), EU MDR, and other applicable global regulations. Hands-on experience with audits (internal, external, regulatory, supplier). Proven expertise in CAPA, risk management, process validation, and complaint handling. Proficiency in quality tools (Root Cause Analysis, Six Sigma, FMEA, SPC, etc.). Excellent leadership, team management, and communication skills. Strong analytical, problem-solving, and decision-making abilities. Proficiency in documentation, reporting, and use of electronic QMS tools. Preferred Skills: Experience with SaMD (Software as a Medical Device) or IoT-enabled medical devices. Knowledge of ISO 27001, IEC 62304 (software), IEC 60601 (safety), and cybersecurity standards. Experience in working with global regulatory bodies (FDA, EU Notified Bodies, TGA, PMDA, etc.). Lean Six Sigma Green Belt/Black Belt certification. Prior experience in supporting regulatory submissions and technical documentation (Design Dossier/Technical File). Location: Thane (West), Mumbai
We are currently seeking a talented Verification And Validation Lead Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry. Job Title : Verification And Validation Lead Engineer Experience : 10-15 years Qualification : B.E/B.Tech or equivalent degree in Electronics and Telecommunication Engineering /Electronics Engineering /Industrial Electronics Engineering. Job Description: Biovantage is looking for a Verification and Validation Lead Engineer to perform end-to-end software/firmware verification and validation for our various Medical Device and Software as a Medical Device (SaMD) product development projects. As a V&V Lead Engineer, you will be actively involved in understanding/authoring the software/firmware requirements, developing test protocols, executing test cases, and creating reports. You will continuously track software bugs and control the overall quality of the software and firmware. Required Skills: 10-13 years of experience in system/software/firmware verification and validation with a focus on any of the regulated industry such as medical device, avionics, or automotive. Experience in software testing for Embedded Software/Firmware, Web Applications & Mobile Applications. Excellent aptitude and reasoning with understanding of Software testing/verification methodologies, tools, and processes. Experience in development, execution and review of verification plans, test methods, test strategies, acceptance criteria, test cases, test reports, and traceability reports. Excellent problem-solving skills and the ability to work independently or as part of a team. Good team player with excellent communication skills, to be able to collaborate and work with cross functional teams. Knowledge of IEC 62304, ISO 13485, ISO 14971 and other relevant medical device regulations and standards. Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports. Ability to work on multiple projects in a deadline driven environment. Strong track record of technical leadership and working in cross-functional teams. Project management skills including planning and estimation of task and milestones desired. Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders . Preferred Skills: Familiarity with Requirements management tools, configuration management tools and test management tools like Git, TestRail, Jira, Helix/TestTrack, Confluence, etc. Experience with software and system risk analysis (per ISO 14971) including fault tree analysis, software failure mode and effects analysis (FMEA). Experience with FDA Guidance for Cybersecurity in Medical devices including threat modelling techniques and security risk management . Responsibilities: Participate in the development of system and subsystem requirements development and review. Lead and contribute to verification and validation of a Medical Device product hardware and software, including but not limited to development of verification plan, review of system and subsystem requirements, design test strategies and methods, write and execute test cases, generate traceability reports, generate test execution reports. Collaborate with Product development teams to understand the product specification, system interfaces, operational requirements, performance requirements, software requirements, software design, etc. to discuss and review test methods and test strategies. Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints. Performs hands-on system integration testing and troubleshooting of technical issues. Performs system level verification against requirements. Creates test plans, procedures and reports, performs, and analyses system set up, and conducts verification and validation activities. Mentor fellow V&V engineers and work to foster an environment of individual development and organization growth. Helps grow the organization by participating in interview process for engineers of various disciplines, working closely with senior leadership. Stay current with industry trends, regulatory guidance, standards, and best practices in medical devices industry to continuously improve our services and maintain our competitive edge. Location: Thane
We are seeking a highly skilled and motivated Lead Embedded Linux Engineer to join our engineering team. This role involves leading the design, development, and deployment of embedded Linux solutions for advanced hardware platforms. The ideal candidate will have strong technical depth in embedded Linux systems, proven leadership in guiding engineering teams, and hands-on experience with BSPs, device drivers, Yocto/Buildroot, and system-level optimization. As the technical leader, you will be responsible for defining system architecture, mentoring team members, ensuring adherence to best practices, and delivering production-quality software for mission-critical products. Key Responsibilities: Lead the architecture, design, and implementation of embedded Linux software for custom hardware platforms (ARM-based SoCs, microcontrollers, etc.). Own the development and maintenance of Linux BSPs, device drivers, kernel modules, and user-space applications. Drive system bring-up, board support, and low-level debugging across multiple hardware targets. Drive board bring-up, bootloader configuration, and hardware/software interface integration (I2C, SPI, UART, USB, Ethernet, BLE/Wi-Fi). Manage Yocto/Buildroot build systems, custom layers, and CI/CD integration for reproducible builds. Collaborate with hardware engineers to define hardware-software interfaces and optimize system performance. Define and enforce coding standards, software development processes, and documentation practices. Mentor junior and mid-level engineers, fostering technical growth and knowledge sharing. Conduct code reviews, design reviews, and provide technical guidance across projects. Partner with QA and Systems Engineering teams to ensure robust testing, validation, and regulatory compliance (e.g., ISO 13485, IEC 62304 for medical devices if applicable). Stay current with advances in embedded Linux technologies, security hardening, and real-time operating extensions. Requirements: Bachelors or Master’s degree in Electronics Engineering, Computer Engineering, Electrical Engineering, Computer Science, or related field. 10+ years of experience in embedded systems software development with at least 5 years in a leadership role. Expert-level proficiency in Embedded Linux development, including: Kernel, BSP, device driver, and middleware development Yocto Project / OpenEmbedded / Buildroot Bootloaders (U-Boot, Barebox, etc.) System performance optimization and debugging (JTAG, GDB, strace, perf, etc.) Strong programming skills in C, C++, and Python/Shell scripting. Deep understanding of hardware/software interfaces (I2C, SPI, UART, USB, PCIe, Ethernet, BLE/Wi-Fi). Experience with Git, CI/CD pipelines, and agile development methodologies. Demonstrated Excellent leadership, communication, and collaboration skills across cross-functional team Preferred: Experience with real-time operating system environments for microcontrollers. Knowledge of security hardening (secure boot, trusted execution, SBOM, vulnerability scanning). Contributions to open-source projects (kernel, Yocto, etc.). Prior experience working in regulated industries, preferably medical devices, with understanding of IEC 62304 lifecycle processes. Familiarity with risk management (ISO 14971) and software documentation practices required for regulatory submissions.
Biovantage employs a lean and efficient team wherein each capable member is involved in inter-disciplinary work, which develops their talent in business areas that go beyond technical know-how. Therefore, while as a Full Stack Developer, you will primarily be responsible for designing, developing, and maintaining the front-end and back-end components of our web applications, you will also work closely with our product, design and engineering teams to deliver high-quality software to clients, and with our management to design and implement novel business ideas and ventures. Position: Full Stack Developer Skills: 2+ years of professional experience in full stack development. Proficiency in front-end technologies: HTML, CSS, JavaScript, and modern frameworks/libraries such as React.js (Specifically Next.js) for the frontend and C#, ASP .NET framework. Strong back-end development skills using languages such as C#, Node.js (JavaScript/TypeScript), Python, or PHP. Experience with database management systems, particularly PostgreSQL. Familiarity with RESTful APIs and web services architecture. Knowledge of version control systems, particularly Git. Experience with cloud platforms such as AWS, Azure, and knowledge of their services offered is a plus. Experience with AI agents and building custom agents. Responsibilities: Develop and maintain web applications using modern front-end and back-end technologies. Collaborate with cross-functional teams to define, design, and ship new features. Write clean, maintainable, and efficient code. Optimize applications for maximum speed and scalability. Troubleshoot and debug issues and perform code reviews. Implement responsive web design principles to ensure our applications work well across various devices and screen sizes. Negotiate and communicate effectively with the clientele. Breakdown requirements into modular tasks and create timelines Stay up to date with emerging technologies and industry trends. Mentor junior developers and contribute to a culture of continuous improvement. Preferred: Experience with CI/CD pipelines and DevOps practices. Understanding of containerization and orchestration tools like Docker and Kubernetes. Knowledge of microservices architecture. Familiarity with Agile/Scrum methodologies. Ability to work independently and manage multiple tasks effectively. Interest in client-facing opportunities Interest in learning novel technologies and working simultaneously with multiple tech-stacks. Strong problem-solving skills and attention to detail. Qualification: Bachelor's or master's degree in information technology, Computer Science or other relevant technical discipline.
As a Senior Mobile Developer, you will play a key role in designing, developing, and maintaining high-quality mobile applications. You will collaborate with cross-functional teams to define, design, and ship new features. The ideal candidate is passionate about mobile technologies and is driven to push mobile technologies to the limits. Position: Senior Mobile Application Developer Required Skills: Java mobile developer with 7+ years of experience in building performant mobile apps on the Android platforms. 2+ years of experience with React Native and shipping apps to both platforms, iOS and Android. Knowledge and experience with background processing on Mobile operating systems, Bluetooth/NFC communication, QR Scanning and Admin applications (applications that control the OS). Strong experience with Android Enterprise, Kiosk-mode Applications and Managed Google Play. Strong experience with posting apps to play store and managing documentation. An extensive understanding of JavaScript, CSS, HTML, functional programming, and front-end languages is required. Rock solid at working with third-party dependencies and debugging dependency conflicts. Ability to write well-documented, clean Java code. Familiarity with native build tools, like XCode, Android Studio. Understanding of REST APIs, the document request model, and offline storage. Responsibilities: Build medical-grade, regulatory-compliant mobile applications, primarily in Java Android, that will be part of medical device systems. Design architecture of mobile applications and communication systems. Work with IoT protocols, Bluetooth, NFC etc. Build pixel-perfect, buttery smooth UIs. Troubleshoot and fix bugs. Maintain code and write automated tests to ensure the product is of the highest quality. Participating in code reviews and providing constructive feedback to enhance code quality. Strong communication and problem-solving skills. Good to Have: Very strong experience in React Native, on top of the required Java Android experience Knowledge or Experience of iOS development using Swift and XCode. Basic experience with web development Qualification: Bachelors or Master’s degree in Information Technology, Computer Science or other relevant technical discipline.
As a Senior Software Engineer, you will primarily be responsible for devloping reliable and robust software, architecting and overseeing the design of our cloud-based systems, taking the lead in tackling complex problems across projects, and ensuring compliance with coding standards. You will also work closely with our product, design, and engineering teams to deliver high-quality, scalable cloud solutions to clients, and with our management to design and implement novel ideas that merge efficient infrastructure design with profitable business initiatives. Position: Senior Software Engineer Responsibilities: Develop robust and reliable software solutions Architect, design, and document end-to-end cloud solutions on Microsoft Azure. Lead technical design reviews, establish architecture patterns, and enforce best practices across the stack. Collaborate with product management and engineering teams to translate business requirements into scalable, reliable system designs. Provide accurate work-effort estimates and technical risk assessments for new features and system enhancements. Define and implement Infrastructure as Code (IaC) and manage CI/CD pipelines for automated, repeatable deployments. Guide the selection and adoption of emerging technologies and AI-assisted development tools to enhance team productivity. Mentor and coach engineering teams; conduct architecture workshops and knowledge-sharing sessions. Drive performance tuning, capacity planning, cost optimization, and security/compliance reviews. Troubleshoot and resolve high-severity production incidents; perform post-mortem analysis and implement corrective actions. Skills: 7-12 years of professional experience in software engineering and architecture. Proven expertise in Microsoft Azure services. Proficiency in front-end technologies: React.js, React Native, Next.js Strong back-end development skills using C# (.NET Core). Strong experience with database management systems, especially PostgreSQL. Experience with IoT, firmware communication (Bluetooth, WiFi, Serial), and associated protocols. Solid understanding of microservices architecture, event-driven design patterns, RESTful APIs. Good to have: Masters degree in Computer Science, or relevant field. Experience with Cybersecurity Procedures: Vulnerability Assessment, Static Code Analysis, Penetration Testing, etc. Azure Solutions Architect Expert or equivalent certification. Strong Experience in CI/CD platforms, including Azure DevOps. Understanding of containerization and orchestration tools like Docker and Kubernetes. Knowledge of microservices architecture and event-driven design patterns. Background in regulated industries (healthcare, medical devices, financial services). Familiarity with Agile/Scrum methodologies. Ability to work independently and manage multiple tasks effectively. Interest in client-facing opportunities. Interest in emerging technologies and multiple tech-stacks. Strong problem-solving skills and attention to detail. Familiarity with containerization and orchestration tools like Docker and Kubernetes (AKS). Knowledge of DevSecOps practices, security frameworks (OWASP, CIS Benchmarks), and compliance standards (ISO 13485, SOC 2). Experience with AI-driven development assistants (e.g., GitHub Copilot). Qualification: Batchelor's degree in Computer Science, Software Engineering, or other relevant technical discipline