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. Show more Show less
About Us: At Digital Health Solutions, we partner with MedTech innovators to provide end-to-end consulting for medical device product development, including full regulatory services and contract manufacturing. Our ISO 13485-certified processes ensure compliance and quality, while our US-India hybrid model delivers cost-effective, scalable solutions. We specialize in critical care life support systems, device integration, and regulatory-driven engineering to help our clients bring innovative medical technologies to the market efficiently and compliantly. 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-cycle—concept, 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, I²C, 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.
As an Embedded Systems Architect at Digital Health Solutions, you will play a key role in leading the design and development of embedded hardware and firmware systems, focusing on microcontroller and microprocessor-based solutions. With our expertise in providing end-to-end consulting for medical device product development, including regulatory services, your contributions will be essential in ensuring compliance and quality while guiding development teams through full product lifecycles. Your responsibilities will include: - Architecting and overseeing the development of embedded systems utilizing 32-bit microcontrollers and application processors. - Driving the complete product life-cycle from concept to long-term maintenance. - Collaborating with cross-functional teams to translate product requirements into robust system architectures. - Leading firmware development in C and C++ for various targets, including board support packages and secure update mechanisms. - Defining board-level hardware architecture in collaboration with hardware engineers. - Ensuring compliance with FDA regulations, ISO standards, and cybersecurity guidance. - Leading risk-management activities and evaluating embedded platforms and communication protocols. - Conducting design and code reviews, establishing best practices, and mentoring junior engineers. - Producing and maintaining high-quality documentation to support system architecture specifications and risk analyses. Qualifications: - Possessing 10+ years of hands-on experience in embedded systems development, preferably in regulated industries. - Proficiency in C and C++ for real-time, safety-critical, and low-level systems. - Deep expertise in embedded Linux development and RTOS. - Strong experience in technical consulting or client-facing product development roles. - Solid understanding of ARM architectures, embedded security, and peripheral interfaces. - Skilled in using debugging and diagnostic tools. - Familiarity with relevant standards and regulatory frameworks. - Experience with wireless protocols and cybersecurity practices. - Demonstrating excellent leadership, communication, and documentation skills. If you are a highly skilled Embedded Systems Architect looking to contribute to innovative medical technologies efficiently and compliantly, we invite you to join our team at Digital Health Solutions.,
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.
About Us: Digital Health Solutions (DHS) is a U.S.-based ISO 13485–certified MedTech engineering and regulatory consulting firm with a strong global presence. In India, we operate through our affiliate, Biovantage Technology Solutions Pvt. Ltd., based in Mumbai. We are seeking a skilled and hands-on Embedded Firmware Engineer 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-cycle—concept, 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, I²C, 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.
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.
As an Embedded Systems Architect at Digital Health Solutions, you will play a key role in leading the design and development of embedded hardware and firmware systems, focusing on microcontroller and microprocessor-based solutions. With our expertise in providing end-to-end consulting for medical device product development, including regulatory services, your contributions will be essential in ensuring compliance and quality while guiding development teams through full product lifecycles. Your responsibilities will include: - Architecting and overseeing the development of embedded systems utilizing 32-bit microcontrollers and application processors. - Driving the complete product life-cycle from concept to long-term maintenance. - Collaborating with cross-functional teams to translate product requirements into robust system architectures. - Leading firmware development in C and C++ for various targets, including board support packages and secure update mechanisms. - Defining board-level hardware architecture in collaboration with hardware engineers. - Ensuring compliance with FDA regulations, ISO standards, and cybersecurity guidance. - Leading risk-management activities and evaluating embedded platforms and communication protocols. - Conducting design and code reviews, establishing best practices, and mentoring junior engineers. - Producing and maintaining high-quality documentation to support system architecture specifications and risk analyses. Qualifications: - Possessing 10+ years of hands-on experience in embedded systems development, preferably in regulated industries. - Proficiency in C and C++ for real-time, safety-critical, and low-level systems. - Deep expertise in embedded Linux development and RTOS. - Strong experience in technical consulting or client-facing product development roles. - Solid understanding of ARM architectures, embedded security, and peripheral interfaces. - Skilled in using debugging and diagnostic tools. - Familiarity with relevant standards and regulatory frameworks. - Experience with wireless protocols and cybersecurity practices. - Demonstrating excellent leadership, communication, and documentation skills.,