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 Culture
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.
What We Offer
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.
The Role
Responsibilities
* 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, risks, regulatory submission, standard compliance, etc.
* Write, debug, and optimize firmware using C/C++ and other relevant programming languages, ensuring high reliability and performance.
* Lead the integration of software with hardware components, ensuring seamless functionality and compliance with design specifications.
* Prepare and maintain comprehensive technical documentation, including design specifications, test plans, test reports, and regulatory compliance documents.
* Lead software testing and validation activities, including unit testing, integration testing, and system testing to ensure product reliability and safety.
* 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.
* 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.
* Engage with clinicians and product users in their clinical setting to elicit user need/functional requirements when required.
* Stay current with the latest industry trends and technologies and drive continuous improvement initiatives within the team and the broader organization.
* Provide technical guidance and mentoring to graduate engineers while fostering a collaborative environment.
Requirements
* BEng in Electronic/Software/Biomedical Engineering or equivalent.
* Minimum of 4 years embedded software/design experience preferably in the medical device industry.
Key Skills
* Proficiency in C/C++.
* A working knowledge of the following standard and guidance documents for the development of software for medical device design:
o IEC/EN 62304 Medical Device Software – Software Lifecycle Processes.
o 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 Qt desirable.
* 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.
Life at Aerogen
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.
* 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.