Work Flexibility: Hybrid We are seeking an experienced Manager – Embedded Systems Development & Testing to lead a high-performing engineering team responsible for the design, development, integration, verification, and validation of embedded systems for next-generation medical devices. The role will provide technical and people leadership across the embedded product lifecycle, from requirements and architecture through software/hardware development, system integration, verification, validation, and product release. The ideal candidate will have strong experience in embedded software, real-time systems, hardware/software integration, automated testing, system verification, and regulated product development, combined with the ability to build and lead engineering teams. What You will do: Key Responsibilities 1. Engineering Leadership • Lead and manage embedded systems development and testing teams responsible for medical device products.Define engineering strategies, development processes, technical direction, and execution plans. • Provide technical leadership across embedded software, firmware, system integration, and verification.Drive execution of multiple concurrent projects while balancing quality, schedule, cost, and technical risks. • Establish clear ownership, accountability, and engineering metrics across the team.Partner with Product Management, Systems Engineering, Quality, Regulatory, Manufacturing, Clinical, and other cross-functional teams. 2. Embedded Systems Development • Lead development of embedded software/firmware for medical devices and connected systems.Guide architecture and design decisions involving:Embedded C/C++RTOSMicrocontrollers and SoCsDevice driversCommunication protocolsUSB/BLE/Wi-Fi/EthernetSensor interfacesMotor/control systemsPower managementBootloaders and firmware update mechanisms • Ensure robust hardware/software integration and system-level performance.Drive reuse of software platforms, common architectures, libraries, and development frameworks across products. 3. Verification & Validation • Lead development and execution of unit, integration, system, and acceptance testing strategies.Establish robust verification methodologies for embedded software and complete medical-device systems. • Drive automated testing, hardware-in-the-loop (HIL), simulation, test automation, and continuous integration where appropriate.Ensure traceability between: User Needs → System Requirements → Software Requirements → Design → Implementation → Verification • Review and approve verification strategies, test plans, test cases, and test results.Drive root-cause analysis and resolution of complex technical issues discovered during development and testing. 4. Quality & Regulatory Compliance • Ensure engineering activities comply with applicable medical-device development processes and organizational quality systems.Work closely with Quality and Regulatory teams to ensure compliance with applicable standards and regulations, such as:ISO 13485IEC 62304IEC 60601, where applicableISO 14971IEC 62366, where applicableCybersecurity requirements applicable to medical devicesApplicable FDA and international regulatory requirements • Ensure appropriate documentation, design controls, risk management, change control, and verification evidence throughout the product lifecycle.Participate in design reviews, risk reviews, audits, and regulatory submissions as required. 5. Test Automation & Engineering Excellence • Establish a modern automated testing strategy for embedded products.Increase automated test coverage and reduce dependence on manual testing. • Promote:CI/CD for embedded systemsAutomated regression testingHardware-in-the-loop testingStatic and dynamic analysis Code coverage Unit testing Integration testing System-level testing. Establish engineering metrics to monitor product quality, test effectiveness, defect escape rates, and development efficiency. 6. Technical Problem Solving • Act as an escalation point for complex embedded-system issues.Lead cross-functional investigation of difficult hardware/software/system failures. • Drive structured root-cause analysis using methodologies such as 5-Why, Fishbone, FMEA, and fault-tree analysis.Ensure corrective and preventive actions are implemented effectively.Provide technical guidance during field issues, customer escalations, and product investigations. 7. People & Talent Leadership • Build, mentor, and retain a strong embedded engineering organization.Define team structure, roles, responsibilities, and technical career paths.Conduct performance management, coaching, and regular career development discussions. • Identify technical skill gaps and establish training and development plans.Recruit high-quality embedded software, firmware, systems, and test engineers.Develop future technical leaders and engineering managers. 8. Project & Program Execution • Work with program/project managers to develop realistic technical schedules and resource plans.Identify technical risks early and establish mitigation plans. • Track milestones, dependencies, defects, technical debt, and engineering deliverables.Communicate project status, risks, and opportunities to senior leadership.Support product launches and sustaining engineering activities. What You Need: Must Have • 13-16 years embedded systems experience with 5+ years people-management/technical leadership. • Strong embedded architecture and system-design knowledge across software, hardware, RTOS, drivers, and interfaces. • Proven experience leading teams through end-to-end product development from requirements to release and sustaining. • Strong understanding of verification, testing, quality, risk management, and regulated product development. • Strong people leadership, mentoring, cross-functional influence, and execution skills. Good to have • Medical-device / safety-critical / regulated product development experience. • Experience with manufacturing/NPD, production, and sustaining engineering. • Hands-on knowledge of motor control, electromechanical systems, embedded Linux, connectivity, and cybersecurity. • Experience with automation, HIL, CI/CD, static analysis, and automated testing. • Previous experience as a Senior Staff/Staff Engineer or Embedded Architect before moving into people management. Travel Percentage: 20%