Medical Engineering Consultants (MEC)

Principal Embedded Software Engineer Lead

IRVINE, CAPosted 30+ days ago

Job summary

  • Job post source

    This job is from a recruiting firm hiring for a separate company.

  • Job overview

    The Principal Embedded Software Engineer Lead at Medical Engineering Consultants (MEC) leads firmware development and integration for active implantable medical devices, ensuring regulatory compliance and advancing medical device technology.

  • Responsibilities and impact

    The role involves leading technology evaluations, firmware architecture development, ensuring compliance with medical device regulations, collaborating with cross-functional teams, managing risk and cybersecurity, developing testing strategies, and supporting regulatory submissions and manufacturing transfer.

  • Experience and skills

    Candidates need a bachelor's degree in a related field, 4+ years in embedded firmware development, 2+ years with implantable or Class III medical devices, strong C/C++ skills, expertise in low-power embedded systems, firmware risk assessment, cybersecurity, and regulatory compliance, plus experience with BLE integration and relevant tools.

  • Work environment and culture

    MEC promotes a culture of innovation, continuous improvement, and knowledge sharing within its R&D teams, emphasizing quality and regulatory compliance in a collaborative environment.

  • Company information

    Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing expert resources and knowledge to improve efficiency, compliance, and quality systems, focusing on FDA and international standards.

  • Job location and travel

    The position requires onsite work at MEC's Irvine, CA location.

  • Unique job features

    The role is distinguished by its focus on implantable medical device firmware development with compliance to stringent regulatory standards and involvement in cutting-edge technologies like BLE, cybersecurity, and real-time embedded systems.

Company overview

Medical Engineering Consultants (MEC) is a specialized firm that provides expert consulting services in the medical engineering sector. They focus on offering solutions and guidance for the development and optimization of medical devices and technologies. MEC generates revenue by partnering with healthcare companies, research institutions, and manufacturers to enhance product design, ensure regulatory compliance, and improve operational efficiencies. The company has a history of innovation and collaboration, playing a crucial role in advancing medical technology. Candidates should be aware of MEC's commitment to quality and its reputation for driving impactful advancements in the healthcare industry.

How to land this job

  • Position your resume to highlight leadership in embedded firmware development, especially within implantable or Class III medical devices, emphasizing compliance with FDA, IEC 62304, ISO 13485, and ISO 14971 standards.

  • Focus on showcasing experience with low-power embedded systems, real-time operating systems (RTOS), BLE integration, cybersecurity risk assessments, and regulatory-compliant firmware development.

  • Apply through Medical Engineering Consultants’ official corporate website and LinkedIn job postings to maximize application visibility and ensure your resume reaches the right hiring channels.

  • Connect with current MEC employees in the embedded software or R&D divisions on LinkedIn; use ice breakers like commenting on recent MEC projects related to implantable devices or asking about their experience with regulatory challenges in firmware development.

  • Optimize your resume for ATS by incorporating keywords such as 'embedded firmware development,' 'IEC 62304,' 'FDA compliance,' 'BLE,' 'real-time operating systems,' and 'medical device cybersecurity' to pass initial screenings effectively.

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