About this role
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 applicable ISO 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.
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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%