Medical Engineering Consultants (MEC) ยท 12 hours ago
Software Engineer - Firmware
Marlborough, MA
Full-time
Hybrid
Mid Level
$0/yr - $0/yr
4+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise. They are seeking a Firmware Engineer to evaluate firmware technologies for active implantable medical devices, ensuring compliance with quality systems and regulatory standards while collaborating with cross-functional teams.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
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
Collaborate with cross-functional teams including hardware engineers, systems engineers, risk management, regulatory affairs and clinical teams to ensure seamless device integration
Maintain 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 and wireless communication e.g. BLE, NFC, RF telemetry
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 510k, PMA or CE Mark submissions involving firmware-related changes
Contribute to the process of transferring the product from development to manufacturing
Foster a culture of innovation, continuous improvement and knowledge sharing within the R&D team
Qualification
Required
Bachelor's degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering or related major
Will look at someone with MS degree plus 2 years of embedded firmware development
4 years of experience in embedded firmware development
Strong C and C# skills for programming microcontroller systems
Expertise in programming for systems and in microcontroller-based firmware development
Experience in firmware risk assessment, cybersecurity and regulatory compliance for implantable devices
Strong project management and communication skills
Detail-oriented and well organized
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
Experience with active implantable medical devices will move to top
Knowledge of ISO 13485 and FDA QSR
Expertise in low-power embedded systems
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase