Firmware/Embedded Software Engineer

Medical Engineering Consultants LLC.; Irvine (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Medical Engineering Consultants LLC is looking for a Firmware/Embedded Software Engineer to evaluate and integrate firmware technologies for active implantable medical devices. This role involves developing firmware, ensuring compliance with medical device regulations, and collaborating with various engineering teams to ensure product quality and safety.

Qualifications

• 3 years of experience in embedded firmware development.
• 1 year in implantable or Class III medical devices.
• Experience in integrating BLE embedded systems.

Responsibilities

• Participate in technology evaluations and validation of firmware architectures.
• Ensure firmware development aligns with IEC 62304 and FDA regulations.
• Collaborate with cross-functional teams for seamless device integration.

Skills

C/C++

Real-time operating systems

Cybersecurity

Firmware risk assessment

Project management

Education

Bachelors degree in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering

Tools

Oscilloscopes

Logic analyzers

Job description

Join to apply for the Firmware/Embedded Software Engineer role at Medical Engineering Consultants (MEC)

Join to apply for the Firmware/Embedded Software Engineer role at Medical Engineering Consultants (MEC)

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Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

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.

Key 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, ISO14971 and other regulatory standards governing medical device firmware.
• Participate in Identifying potential risks of 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- 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 integration to sustaining engineering.
• Contribute to a culture of innovation, continuous improvement and knowledge sharing within the R&D team.
  
  

Quality Systems Duties And Responsibilities

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Requirements

• Bachelors 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.
• Strong C/C++ skills for programming microcontroller systems.
• 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 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 Qualifications

• 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 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.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering and Information Technology

• Industries

  Business Consulting and Services

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