Senior Electronic Engineer II

Job description

About Aerogen: Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards, including being named Galway Chamber Company of the Year 2025, and twelve-time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries. Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes. Our business continues to grow rapidly across the globe and, as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. What is the role? The Senior Electronic Engineer II provides technical leadership and ownership of electronic hardware deliverables from concept through production and sustaining support. The role applies sound engineering judgement to resolve complex technical issues and ensure compliance with applicable quality and regulatory requirements. What are the key responsibilities? Leadership: • Promote team engagement and a positive engineering culture through constructive technical collaboration, knowledge sharing, timely feedback, and respectful challenge. • Model the company's core values through respectful leadership, professional conduct, accountability, and a consistent commitment to teamwork. • Mentor junior team members through technical coaching, design-review feedback, knowledge sharing, and support for their ongoing development. Task management: • Provide technical input to define the hardware scope, goals, deliverables, estimates, dependencies, and risks within the overall project plan. • Coordinate with project managers, embedded software engineers, and other stakeholders to align project goals and deliverables. • Provide technical support to manufacturing for sustaining production. • Apply failure analysis skills to determine and document root cause of product, system or component failure. Technical expertise: • Develop and maintain electronic hardware, ensuring compliance with industry standards and regulations such as IEC 60601-1 and FDA guidelines relating to medical device design and manufacture. • Lead the design and implementation of electronic hardware, including requirements, architecture, schematics, component selection, design reviews, verification, validation, and transfer to production. • Lead the investigation and resolution of hardware issues, documenting root cause, risk, corrective actions, and validation of the solution. • Prepare and maintain test plans, protocols, and reports that provide requirements traceability, reproducible test methods, and objective evidence. Quality and regulatory compliance: • Ensure hardware development activities comply with applicable medical-device regulations and standards, including EU and FDA requirements, IEC 60601-1, and ISO 14971 standards. • Conduct hardware design and documentation reviews. • Share ownership of hardware development processes and maintain them in line with current standards and engineering best practices. Innovation and continuous improvement: • Stay current with advancements in electronic hardware design, medical device technology, and relevant standards and guidance documents. • Identify and implement best practices, tools, and methodologies to enhance development efficiency and product performance. • Drive continuous improvement initiatives within the team. • Complete documentation for IP filings, freedom to operate, literature reviews, R&D tax credit applications and grant applications. • Use of approved AI tools for testing, data analysis, and report writing, while independently verifying their outputs. Collaboration: • Collaborate across R&D, Manufacturing, Operations, QA/RA, Commercial, and Marketing to align technical decisions, manage risks, and support successful product development and lifecycle activities. • Provide regular, accurate updates on hardware deliverables to the project manager and management. Engagement: • Engage with clinicians and users in their working environments to understand workflows, identify unmet needs, and translate observations into clear, documented user needs and functional requirements. • Perform other assigned tasks as directed by your manager. What education and experience are required? • Bachelor of Engineering in Electronic Engineering or Equivalent. • Minimum of six years’ hardware design experience, including experience in regulated product development; medical-device industry experience is strongly preferred. What key skills will make you great at the role? • Proficiency in analog and digital electronic circuit design, including requirements analysis, schematic capture, component selection, design calculations, simulation, prototyping, bring-up, and troubleshooting. • Experience creating and reviewing medical-device hardware deliverables, including hardware requirements, architecture and design documentation, schematics, bills of materials, risk-management inputs, design-review records, and verification and validation documentation. • In-depth understanding of the following standards and guidance documents applicable to hardware development for medical devices is required: • IEC/EN 60601 Series for Medical Electrical Equipment • Applicable FDA guidance documents for the design, verification, validation, and manufacture of medical devices. • Knowledge of embedded software design as it relates to hardware design. • Experience planning, executing, and documenting hardware verification and validation for medical electrical equipment. • Experience supporting medical electrical equipment from prototype development and production transfer through ongoing manufacturing and sustaining engineering. • Proficiency with electronic-design-automation tools for schematic capture and PCB development, such as OrCAD Capture and PCB Designer, or equivalent platforms. • Experience with microcontroller interfaces and peripherals, including SPI, I²C, UART, and ADCs. • Experience integrating wireless communication modules, including Bluetooth and cellular technologies, into electronic hardware designs. • Ability to convey technical concepts to non-technical stakeholders. • Strong interpersonal skills with the ability to collaborate cross functionally. • High level of accuracy and attention to detail. • Self-directed with effective time-management skills and willingness to learn new skills and adapt to meet current challenges. • Openness to continuous learning and improvement. • Flair for innovation. • Commitment to maintaining high ethical and professional standards. • Ability to produce clear, accurate, and traceable engineering documentation covering design evolution, technical decisions, reviews, and test results. • Proficiency in analysing engineering information and detailing results using Microsoft Word, Excel, PowerPoint, and Copilot tools What is it like to work at Aerogen? Our purpose is to transform patients' lives and innovation is embedded in our culture. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of