Electrical / Embedded Software Engineer

at  Pulmotree Medical GmbH

IHRE AUFGABEN

Important notice: We believe that everything that belongs together comes together. Therefore, we would like to kindly ask external recruiters and headhunters to refrain from making referral proposals.

We are seeking a highly skilled and versatile Electrical and Embedded Software Engineer to join our innovative life science company focused on targeted drug delivery solutions. In this role, you will be responsible for designing, developing, testing and maintaining both the electrical components and the embedded software for our advanced respiratory devices. The ideal candidate is passionate about improving patient outcomes through technology and possesses a strong background in both electrical engineering and embedded systems development. In this exciting role the Electrical Engineer will have responsibility for Hardware and Software Architecture and Development, related usability and risk management amongst other topics as part of the internal new products development team. This person shall ensure the products’ hardware and software are verified and validated.

• Design, development, testing and maintaining of electrical medical devices (IEC 60601, ISO 13485, ISO 14971) and its software
• Creation of Hardware and Software Architecture
• Create and review detailed electrical schematics, PCB layouts, and wiring diagrams.
• Select and evaluate components to ensure reliability, cost-effectiveness, and compliance with medical standards.
• Embedded software development (microcontroller ESP32, I2C, SPI, GPIO, C/C++/C#, BLE, WIFI)
• Development and documentation of software according to IEC 62304
• Hardware and Software Verification and Validation
• Unit and Modul Testing
• Troubleshoot and resolve electrical issues, ensuring the safety and performance of medical devices.
• Implementing and managing Cybersecurity for medical devices (ISO 80001, ISO 81001, AAMI TIR57, MDCG and FDA guidance documents)
• Ensure the safety and security of software, adhering to industry standards and regulatory requirements, such as IEC 62304.
• Write and maintain clear, well-documented code and technical documentation according to IEC 62304
• Managing (sub-) projects according to the internal standards
• Collaborate with cross-functional teams, including software, mechanical, and clinical experts, to develop integrated solutions.
• Stay current with emerging trends and technologies in electrical engineering and medical device development.
• Represents PULMOTREE Medical within electrical and Embedded SW responsibilities to internal and external partners and acts as an entrepreneur with focus on business needs

• Design, development, testing and maintaining of electrical medical devices (IEC 60601, ISO 13485, ISO 14971) and its software
• Creation of Hardware and Software Architecture
• Create and review detailed electrical schematics, PCB layouts, and wiring diagrams.
• Select and evaluate components to ensure reliability, cost-effectiveness, and compliance with medical standards.
• Embedded software development (microcontroller ESP32, I2C, SPI, GPIO, C/C++/C#, BLE, WIFI)
• Development and documentation of software according to IEC 62304
• Hardware and Software Verification and Validation
• Unit and Modul Testing
• Troubleshoot and resolve electrical issues, ensuring the safety and performance of medical devices.
• Implementing and managing Cybersecurity for medical devices (ISO 80001, ISO 81001, AAMI TIR57, MDCG and FDA guidance documents)
• Ensure the safety and security of software, adhering to industry standards and regulatory requirements, such as IEC 62304.
• Write and maintain clear, well-documented code and technical documentation according to IEC 62304
• Managing (sub-) projects according to the internal standards
• Collaborate with cross-functional teams, including software, mechanical, and clinical experts, to develop integrated solutions.
• Stay current with emerging trends and technologies in electrical engineering and medical device development.
• Represents PULMOTREE Medical within electrical and Embedded SW responsibilities to internal and external partners and acts as an entrepreneur with focus on business need