Manager Embedded Systems (Medical Devices)

Key Responsibilities

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.

• 715 years of experience with 35 years in medical devices and leadership.

• Strong medical device lifecycle and risk management knowledge.