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 16 million patients in over 75 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 Senior 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?  
• Collaborate as a member of cross-functional project teams in developing products from concept through to commercialisation.
• Conduct product design and development in accordance with CE & FDA regulations relating to medical device design and manufacture.
• Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance. 
• Conduct use and design risk assessment, implementing controls or mitigations to reduce risk levels.
• Conduct and record proof of principle testing of prototypes to confirm feasibility of ideas and concepts
• Engage with clinicians and product users in their clinical setting to elicit user need/functional requirements
• Prepare technical documentation in clear and concise terms in accordance with good engineering practice. 
• Participate in technical design reviews to ensure electrical design integrity and safety are achieved.
• Apply failure analysis skills to determine and document root cause of product system or component failure.
• Conduct assessment of the competitive IP landscape, including freedom to operate and literature review.
• Prepare invention disclosures and patent applications to ensure protection of intellectual property.
• Maintain current and accurate records of the iterative design process, trial and error and experimental steps to            support the design history file and for R&D grant and tax credit submissions.
• Liaise closely within R&D, Science, Manufacturing, Operations, Quality, Sales and Marketing functions through       the product development lifecycle.
• Maintain current working knowledge of the key international standards, regulations and regulatory guidance direction that govern the medical devices industry including medical electrical equipment.
• Communicate regular and accurate updates on project deliverables including any risk of divergence from the plan to the project leader and/or Aerogen management.
• Maintain and enhance engagement and positive culture within the team and organization.
• Demonstrates and models through leadership style and behavior, respect for company core values and a commitment to teamwork.
• Perform other assigned tasks as directed by your manager.

What education and experience are required?  
Degree or equivalent in Electronic Engineering with a minimum of 8 years design experience preferably in the medical device or consumer device industries. 

What key skills will make you great at the role? 
• Proficient in electronic circuit design – analog and digital.
• A working knowledge of the following regulatory standards for the development of hardware for medical device design: 
• IEC/EN 60601 Series for Medical Electrical Equipment.  
• Experience in creating the hardware deliverables required for medical electrical device development.
• 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.
• Knowledge of Microcontroller interfacing such as SPI, I2C, UART, ADCs etc. 
• Technical input and review of related project documentation.
• Prepare invention disclosures and patent fillings as appropriate.
• Strong interpersonal skills with the ability to collaborate in a multi-disciplinary team.
• Self-directed with effective time-management skills.
• Flair for innovation.
• Ability to document engineering evolution, development, testing, and reporting 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. There’s 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 for more information 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.