Position Overview :

The Manager - Embedded Systems (Medical Devices) will lead the architecture, development, verification, and full lifecycle management of embedded technologies used in medical equipment and healthcare solutions. This role requires deep expertise in embedded engineering, strong command of global medical device regulations, and demonstrable experience delivering safe, reliable, and compliant products. The role oversees cross-functional engineering teams to ensure all systems meet clinical, regulatory, quality, and manufacturing expectations.

Key Responsibilities :

- Lead system architecture, embedded firmware development, and hardware-software integration for medical devices.

- Oversee development of safety-critical features, real-time processing, sensor integration, and data acquisition systems.

- Ensure all designs comply with IEC 60601, IEC 62304, ISO 14971, and ISO 13485 standards.

- Drive selection and governance of microcontrollers, RTOS, embedded Linux platforms, and communication stacks.

- Lead structured design reviews focused on risk mitigation, verification planning, traceability, and safety.

- Ensure full compliance with IEC 62304 across the complete software development lifecycle.

- Own risk management execution aligned to ISO 14971 and ISO 13485.

- Contribute to usability engineering aligned with IEC 62366.

- Partner with QA/RA teams for CE, FDA, CDSCO documentation.

- Enforce DHF, DMR, and traceability matrices.

- Lead embedded teams across firmware, electronics, and verification.

- Own planning, resource allocation, scheduling, and budgets.

- Mentor teams on safety-critical development and documentation.

- Collaborate with clinical, QA/RA, design, and manufacturing teams.

- Drive concept to manufacturing transfer.

- Oversee integration of sensors, actuators, wireless modules, and cloud interfaces.

- Ensure SIL/HIL testing, DVT, and clinical evaluation support.

- Lead root-cause analysis of field and reliability issues.

- Translate clinical needs into system and software requirements.

- Support medical-grade component procurement.

- Coordinate regulatory audits and certifications.

- Engage hospitals, clinicians, and validation labs.

Technical Leadership :

- Lead system architecture, embedded firmware development, and hardware-software integration for medical devices.

- Oversee development of safety-critical features, real-time processing, sensor integration, and data acquisition

systems.

- Ensure all designs comply with IEC 60601, IEC 62304, ISO 14971, and ISO 13485 standards.

- Drive selection and governance of microcontrollers, RTOS, embedded Linux platforms, and communication stacks.

- Lead structured design reviews focused on risk mitigation, verification planning, traceability, and safety.

Medical Device Compliance & Quality :

- Ensure full compliance with IEC 62304 across the complete software development lifecycle.

- Own risk management execution aligned to ISO 14971 and ISO 13485.

- Contribute to usability engineering aligned with IEC 62366.

- Partner with QA/RA teams for CE, FDA, CDSCO documentation.

- Enforce DHF, DMR, and traceability matrices.

Project & People Management :

- Lead embedded teams across firmware, electronics, and verification.

- Own planning, resource allocation, scheduling, and budgets.

- Mentor teams on safety-critical development and documentation.

- Collaborate with clinical, QA/RA, design, and manufacturing teams.

Product Development & Lifecycle Management :

- Drive concept to manufacturing transfer.

- Oversee integration of sensors, actuators, wireless modules, and cloud interfaces.

- Ensure SIL/HIL testing, DVT, and clinical evaluation support.

- Lead root-cause analysis of field and reliability issues.

Stakeholder & Cross-Functional Coordination :

- Translate clinical needs into system and software requirements.

- Support medical-grade component procurement.

- Coordinate regulatory audits and certifications.

- Engage hospitals, clinicians, and validation labs.

Required Skills & Qualifications :

- C/C++ embedded programming, RTOS, and low-level firmware.

- Experience with ARM Cortex, MSP, PIC microcontrollers; embedded Linux preferred.

- Medical-grade communication protocols: BLE, USB, RS-485, CAN, HL7/FHIR.

- Biomedical sensors: optical, pressure, ECG/EKG, SpO- , temperature.

- Medical device cybersecurity and encryption.

- Advanced debugging and test automation.

- 7 - 15 years of experience with 3 - 5 years in medical devices and leadership.

- Strong medical device lifecycle and risk management knowledge.

Education :

- Bachelor's or Master's degree in Electronics, Electrical, Computer, Biomedical Engineering, or related fields.

Preferred Experience :

- CE Class C, FDA Class II/III, or CDSCO Class C/D devices.

- Dialysis, diagnostics, patient monitoring, or therapeutic devices.

- IEC 60601-1 Electrical Safety and IEC 60601-1-2 EMC.

- Cloud-connected medical devices, RPM, or AI-assisted diagnostics.