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 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 person in this role is responsible for design and development of respiratory care medical devices to improve the lives of patients worldwide.
What are the key responsibilities?
- Software Architecture and Design: Lead the design and architecture of embedded software systems, ensuring robustness, scalability, and performance. Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance, etc.
- Firmware Development: Write, debug, and optimize firmware using C/C++ and other relevant programming languages, ensuring high reliability and performance.
- System Integration: Lead the integration of software with hardware components, ensuring seamless functionality and compliance with design specifications.
- Documentation: Prepare and maintain comprehensive technical documentation, including design specifications, test plans, test reports, and regulatory compliance documents. Complete documentation for intellectual property filing, grant applications, R&D tax credit applications etc. as applicable.
- Testing and Validation: Lead software testing and validation activities, including unit testing, integration testing, and system testing to ensure product reliability and safety.
- Collaboration: Collaborate closely as a member of cross functional team with R&D, Manufacturing, Operations, Quality, Sales, and Marketing functions through the product development lifecycle from concept through to commercialization.
- Regulatory Compliance: Ensure that all software development activities comply with relevant medical device regulations and standards, such as ISO 13485, IEC 62304, and FDA guidelines relating to medical device design and manufacture.
- User Engagement: Engage with clinicians and product users in their clinical setting to elicit user need/functional requirements when required.
- Continuous Improvement: Stay current with the latest industry trends and technologies and drive continuous improvement initiatives within the team and the broader organization. Maintain current working knowledge of the key international standards, regulations, and specific guidance documentation that governs the medical devices industry including medical electrical equipment.
- Mentorship: Provide technical guidance and mentoring to graduate engineerswhile fostering a collaborative environment.
- Perform other assigned tasks as directed by your manager.
What education and experience are required?
- BEng in Electronic/Software/Biomedical Engineering or equivalent.
- Minimum of 4 years embedded software/design experience preferably in the medical device industry.
What key skills will make you great at the role?
- Proficiency in C/C++
- A working knowledge of the following standard and guidance documents for the development of software for medical device design is required:
- IEC/EN 62304 Medical Device Software Software Lifecycle Processes
- FDA Guidance Documentation
- Specific experience of software development related to verification and validation for medical electrical equipment.
- Proficiency in software design for 8/16/32 bit Microchip microprocessors using Embedded C
- Experience of using graphical frameworks for embedded targets, such as Qtdesirable.
- Knowledge of low power analog & digital circuits including interfacing with Microcontrollers such as SPI, I2C, UART, ADCs etc.
- Familiar with interfacing of wireless communication modules (Bluetooth, LoRa etc.)
- Experience in creating software deliverables for medical device new product development.
- Familiar with software development tools such as MPLAB X, Compilers, ICD, Visual Studio etc.
- Working knowledge of Software Configuration Management tools (Bitbucket or similar) and Software Issue Tracking tools (JIRA or similar)
- Strong interpersonal skills with the ability to collaborate in a multi-disciplinary team.
- High level of accuracy and attention to detail in both coding and documentation.
- Self-directed with effective time-management skills and willingness to learn new skills and adapt to changing project requirements.
- Flair for innovation.
- Ability to document engineering evolution, development and testing using MS Office Applications such as Word, Excel, PowerPoint etc.
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.
