Global TA Program Lead

TALENT Software Services; United States; On-site; USD 146,000 - 166,000; Full time

Job summary

A leading company seeks an experienced Embedded Software Engineer in Irvine, CA. This role involves evaluating and integrating firmware for active implantable medical devices, ensuring regulatory compliance, and requires a deep understanding of embedded systems. Candidates should have a strong background in real-time firmware development and teamwork with regulatory and clinical teams.

Qualifications

• 3+ years of experience in embedded firmware development.
• 1+ years in implantable or Class III medical devices.
• Knowledge of PC application development (C#.Net) and BLE integration.

Responsibilities

• Support firmware development of active implantable medical devices.
• Ensure compliance with IEC 62304 and FDA regulations.
• Collaborate with cross-functional teams for device integration.

Skills

Embedded systems

System integration

Firmware risk assessment

Cybersecurity

Project management

Education

Bachelor’s degree in Computer Science

Bachelor’s degree in Computer Engineering

Tools

Oscilloscopes

Logic analyzers

Job description

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TALENT Software Services provided pay range

This range is provided by TALENT Software Services. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $75.00/hr

Are you an experienced Software Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Software Engineer to work at their company in Irvine, CA.

Position Summary: As an Embedded Software Engineer, you will be part of the evaluation and integration of firmware technologies for active implantable medical devices. As a hands-on contributor, you will support integration activities and firmware development of implantable devices, ensuring compliance with medical device regulations. This role requires expertise in embedded systems, system integration, real-time firmware development, and regulatory-compliant medical device firmware development. You will use your expertise in embedded systems, system integration, real-time firmware development, and regulatory-compliant medical device firmware development.

Primary Responsibilities/Accountabilities:

• Participate in technology evaluations, technical specification development, technical assessments, and validation of firmware architectures, embedded software, and system integration aspects of active implantable medical devices.
• Support the firmware specification development, firmware architecture, embedded firmware development, and integration for active implantable medical devices.
• Ensure that firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971, and other regulatory standards governing medical device firmware.
• Participate in identifying potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies.
• Ensure acquired firmware meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance 62443.
• Collaborate with cross-functional teams, including hardware engineers, systems engineers, risk management, regulatory affairs, and clinical teams, to ensure seamless
• device integration.
• Create, maintain, or update thorough design documentation, traceability matrices, and software development lifecycle (SDLC) artifacts for regulatory submissions.
• Participate in software and system risk management activities throughout the SDLC.
• Participate in testing strategies (Unit/Integration) and design verification protocols to verify firmware functionality.
• Provide technical inputs on low-power embedded systems, wireless communication (e.g., BLE, NFC, RF telemetry), and real-time operating systems (RTOS).
• Establish and document firmware development lifecycle (SDLC) artifacts and processes
• to align with internal quality management systems (QMS).
• Perform firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
• Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes.
• Contribute to the process of transferring the product from integration to sustaining engineering.
• Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

• Bachelor’s degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major
• 3+ years of experience in embedded firmware development
• 1+ years in implantable or Class III medical devices.
• Real-time operating systems (RTOS), and microcontroller-based firmware development.
• Experience in firmware risk assessment, cybersecurity, and regulatory compliance for implantable devices.
• Experience using oscilloscopes, logic analyzers, and other related tools.
• Strong project management and communication skills.
• Detail-oriented and well organized.
• Experience in integrating BLE embedded systems with iOS, Android and Windows applications.
• Knowledge of PC application development in Microsoft Visual Studio (e.g. C#.Net).
• Hands-on experience with oscilloscopes, logic analyzers, and other related tools.

Preferred:

• Knowledge of ISO 13485 and FDA QSR.
• Experience with mergers & acquisitions (M&A) due diligence in the medical device sector.
• Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices.
• Expertise in BLE (Bluetooth Low Energy) in embedded systems, including peripheral, central, dual roles, pairing, GATT profiles, security, and custom services.
• Low-level understanding of BLE software stacks (e.g,. those from On Semi, Nordic) and
• Experience in optimizing BLE software stack for performance constraints and ultra-low power consumption constraints.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology and Engineering

• Industries

  Manufacturing

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