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
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- Engineering Leadership
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Lead and manage embedded systems development and testing teams responsible for medical device products.
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Define engineering strategies, development processes, technical direction, and execution plans.
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Provide technical leadership across embedded software, firmware, system integration, and verification.
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Drive execution of multiple concurrent projects while balancing quality, schedule, cost, and technical risks.
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Establish clear ownership, accountability, and engineering metrics across the team.
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Partner with Product Management, Systems Engineering, Quality, Regulatory, Manufacturing, Clinical, and other cross-functional teams.
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- Embedded Systems Development
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Lead development of embedded software/firmware for medical devices and connected systems.
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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
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Ensure robust hardware/software integration and system-level performance.
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Drive reuse of software platforms, common architectures, libraries, and development frameworks across products.
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- Verification & Validation
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Lead development and execution of unit, integration, system, and acceptance testing strategies.
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Establish robust verification methodologies for embedded software and complete medical-device systems.
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Drive automated testing, hardware-in-the-loop (HIL), simulation, test automation, and continuous integration where appropriate.
Ensure traceability between:
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User Needs → System Requirements → Software Requirements → Design → Implementation → Verification
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Review and approve verification strategies, test plans, test cases, and test results.
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Drive root-cause analysis and resolution of complex technical issues discovered during development and testing.
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- Quality & Regulatory Compliance
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Ensure engineering activities comply with applicable medical-device development processes and organizational quality systems.
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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
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Ensure appropriate documentation, design controls, risk management, change control, and verification evidence throughout the product lifecycle.
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Participate in design reviews, risk reviews, audits, and regulatory submissions as required.
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- Test Automation & Engineering Excellence
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Establish a modern automated testing strategy for embedded products.
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Increase automated test coverage and reduce dependence on manual testing.
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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.
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- Technical Problem Solving
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Act as an escalation point for complex embedded-system issues.
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Lead cross-functional investigation of difficult hardware/software/system failures.
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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.
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Provide technical guidance during field issues, customer escalations, and product investigations.
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- People & Talent Leadership
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Build, mentor, and retain a strong embedded engineering organization.
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Define team structure, roles, responsibilities, and technical career paths.
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Conduct performance management, coaching, and regular career development discussions.
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Identify technical skill gaps and establish training and development plans.
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Recruit high-quality embedded software, firmware, systems, and test engineers.
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Develop future technical leaders and engineering managers.
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- Project & Program Execution
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Work with program/project managers to develop realistic technical schedules and resource plans.
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Identify technical risks early and establish mitigation plans.
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Track milestones, dependencies, defects, technical debt, and engineering deliverables.
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Communicate project status, risks, and opportunities to senior leadership.
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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%