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 the extended team member responsible for testing and driving quality into the embedded software solutions in accordance with IEC 62304 for respiratory care medical devices to improve the lives of patients worldwide.
What are the key responsibilities?
- Software Planning: Contribute to product life cycle activities related to software verification of the all the software deliverables considering project objectives, schedules, budgets, risks, and regulatory compliance.
- Test Development: Define guidelines for writing manual tests and implement coding practices for automated tests. Design and Development of required test scripts for automated tests/ test protocols required to verify the software deliverables that meet technical and functional requirements.
- Test Execution: Test the functionality of software applications or systems software. Providing timely reports for verification activities. Execute test plans and scripts designed to detect problems in software applications and systems
software and ensures that it meets technical and functional requirements.
- System Integration: Assist in the integration of software with hardware components, ensuring seamless functionality and compliance with design specifications.
- Documentation: Prepare and maintain technical documentation test plans in accordance with IEC62304 and FDA guidance. Participate in risk management activities including system risk analysis (ISO14971) as related to software. Provide feedback on test designs, document test results and recommend quality improvements.
- Collaboration: Collaborate closely as a member of a cross-functional team with R&D, Manufacturing, Operations, Quality, Sales, and Marketing functions through the product development lifecycle from concept to commercialisation.
- Regulatory Compliance: Assist in ensuring that all software development activities comply with relevant medical device regulations and standards, such as ISO 13485, IEC 62304, ISO 14971 and FDA guidelines relating to medical devicedesign and manufacture.
- User Engagement: Engage with clinicians and product users in their clinical setting to elicit user needs and functional requirements when required.
- Continuous Improvement: Stay current with the latest industry trends and technologies and contribute to continuous improvement initiatives within the team. Maintain current working knowledge of the key international standards, regulations, and specific guidance documentation that governs the medical devices industry, including medical electrical equipment. Review test automation frameworks, tools, techniques, and methodologies.
- Mentorship: Seek guidance and mentorship from senior engineers while contributing positively to 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 1-year embedded software automated, semi-automated & manual testing experience, preferably in the medical device industry.
What key skills will make you great at the role?
- Skilled in C/C++/Python/JavaScript.
- A working knowledge of the following standard and guidance documents for the verification of software for medical device is desired:
- IEC/EN 62304 Medical Device Software Software Lifecycle Processes
- FDA Guidance Documentation
- Experience of software development related to verification and validation for medical electrical equipment is desired.
- Familiarity with testing methodologies for microcontrollers and embedded devicesis desired.
- Familiar with testing of wireless communication modules (Bluetooth, Wi-Fi, Cellular, LoRa etc.)
- Working knowledge of Software Configuration Management tools (Git 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.
