Description

About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the Role
We are seeking an experienced and skilled Senior Engineer to join our team. In this role, you will be part of evaluation, integration of software and firmware technologies for medical devices. As a technical hands-on contributor, you will execute integration activities and support software development, ensuring compliance with medical device regulations. This role requires experience with application software development, embedded systems, android platform, test frameworks, and regulatory compliant medical device software development processes.

What you'll do:

• Participate in technology evaluations, technical assessments and validation of software architectures, embedded software, and system integration aspects of acquired implantable
  medical devices.
• Support software architecture, development, testing strategies and risk management activities for software applications
• Evaluate compliance and ensure software/firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical devices.
• Contribute to defining test strategies (Unit/Integration) and draft design verification protocols to verify software/firmware functionality post-acquisition.
• Support software/ firmware testing, debugging, and verification e??orts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test
  environments.
• Identify potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies. Ensure acquired software meets medical device cybersecurity and safety
  standards, including FDA premarket cybersecurity guidance, IEC 62443.
• Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory a??airs, manufacturing and PMO to ensure seamless device integration.
• Establish and document software development lifecycle (SDLC) artifacts to align with internal quality management systems (QMS). Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
• Provide technical inputs on low-power embedded systems, wireless communication (e.g., BLE, NFC, RF telemetry), and real-time operating systems (RTOS).
• Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes.
• Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
• Participate in technology evaluations, technical assessments and validation of software architectures, embedded software, and system integration aspects of acquired implantable medical devices.

What We Look For:

• B.S or M.S in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major.
• 5+ years of experience in software development, with 1+ years in embedded or application software for medical devices.
• Experience with capital equipment; including hardware/firmware/software elements. 
• Sound knowledge of software engineering principles and practices. Knowledge of programming languages such as Swift, Java, Dart, or Objective-C and mobile operating systems and platforms such as iOS and Android.
• Experience in developing mobile applications in an FDA regulated environment or other regulated industry.
• Strong C/C++ skills for programming microcontroller systems.
• Knowledge and use of OOP design principles, API design principles.
• Knowledge in low-power embedded systems, real-time operating systems (RTOS), and microcontroller-based firmware development.
• Strong time management and communication skills.
• Experience with mergers & acquisitions (M&A) due diligence in the medical device sector.
• Experience in risk assessment, cybersecurity, and regulatory compliance for implantable devices. Knowledge of ISO 13485 and FDA QSR is desired.
• Experience using oscilloscopes, logic analyzers, and other related toolsDetailed knowledge of BLE stacks and BLE API on mobile platforms.
• 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 secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices.

ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor. 

Summary