Job Description
About Aerogen: Headquartered in the vibrant city of Galway, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients' lives every day, having already reached 20 million patients in over 80 countries. 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, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing 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. Join us as we continue to #discoverbetter. What is the role? The Principal Electronic Engineer will design and develop medical devices in line with CE & FDA regulations relating to medical device design, collaborating as a member of cross-functional project teams in developing products from concept through to commercialisation, improving the lives of patients worldwide. What are the key responsibilities? Leadership: Ability to manage direct reports including assigning goals and ensuring accountability within the team. Maintain and enhance engagement and positive culture within the team and organization. Conduct performance reviews, provide feedback, and identify growth opportunities for junior team members. Demonstrates and models through leadership style and behavior, respect for company core values and a commitment to teamwork. Mentor and support team members in their career development. Task Management: Oversee the hardware development lifecycle, from concept to production. Ensure projects are completed on time, within scope, and within budget. Define project scope, goals, and deliverables. Coordinate with project managers, embedded software engineers, and other stakeholders to align project goals and deliverables. Planning and assignment of work tasks. Providing technical support to manufacturing for sustaining production. Apply failure analysis skills to determine and document root cause of product system or component failure. Strategic Planning: Capability to align engineering goals with organizational objectives. Resource allocation and budgeting. 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. Direct the design and implementation of the hardware deliverables. Resolve hardware issues. Quality and Regulatory Compliance: Ensure all hardware development activities adhere to medical device regulations and standards (e.g., EU MDR, FDA 510k, IEC 60601-1, ISO 14971). Conduct hardware design and documentation reviews, delivering high quality hardware deliverables. Shared ownership of hardware development processes and maintaining them to current standards and best practice. Innovation and Continuous Improvement: Stay up to date 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 intellectual property filings, freedom to operate, literature reviews, R&D tax credit applications and grant applications. Collaboration: Collaborate within R&D, Manufacturing, Operations, QA/RA, Commercial, and Marketing functions as necessary. Communicate regular and accurate updates on project deliverables including any risk of divergence from the plan to the project manager and/or management. User Engagement: Engage with clinicians and users in their environment to elicit user needs/functional requirements. What education and experience are required? BEng or equivalent in Electronic Engineering. Minimum 9 years hardware design experience preferably in the medical device industry. What key skills will make you great at the role? Proficient in electronic circuit design analog and digital. Experience in creating the hardware deliverables required for medical electrical device development. In depth understanding of the following standard and guidance documents for the development of hardware for medical device design is required: IEC/EN 60601 Series for Medical Electrical Equipment FDA Guidance Documentation Knowledge of embedded software design as it relates to hardware design. Experience of hardware validation for medical electrical equipment. Support of medical electrical equipment manufacturing from prototype to production and sustaining of same. Experience using development tools such as OrCAD Capture and PCB Designer. Experience of Microcontroller interfacing such as SPI, I2C, UART, ADCs etc. Familiar with the interfacing of wireless comms modules (Bluetooth, Cellular etc.). Technical input and review of related project documentation. Effective verbal and written communication skills. 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 document engineering evolution, development and testing. What is it like to work at Aerogen? Our purpose is to transform patient lives, and our ethos is to #discoverbetter. 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. Theres something for everyone! Here is an idea of what we offer: Excellent medical care. Bonus & Pension. Aerogen Connect our employee led programme which supports our global teams to unite and have fun. We pledge 1% of profits and time to charities and organisations. Check out our careers website to discover more about Life at Aerogen. Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact. #J-18808-Ljbffr