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Senior Biocompatibility Materials Engineer

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 successful candidate will work with Internal Technology, Product and Process Development groups and external partners to lead, plan, organize biological safety risk assessments on medical devices in accordance with current national and international regulations. This is inclusive of the development of the testing strategies to minimize risk to meet the applicable regulatory requirements.  

What are the key responsibilities?   
• Site Subject Matter Expert for all Biocompatibility & Microbiology activities in Aerogen.
• Providing technical excellence in the field and selection of testing strategies and materials for technical, product and sustaining activities.
• Knowledgeable of the associated quality system, regulatory requirements and interpretation of same ISO/FDA/MDR/AAMI related to biocompatibility & microbiology.
• Keeping abreast of the changing medical device/regulatory environments in materials biocompatibility and patient safety and disseminate relevant critical changes to the business.
• Ensuring compliance to all relevant regulations biocompatibility and microbiology, which includes maintaining all quality systems and related documentation.
• Collaboratively work with external and contract testing services.
• Support and lead Project Teams with respect to Biocompatibility testing strategies, & validation requirements.
• Ability to perform biocompatibility and microbiological risk-based change assessments determinations as required in product or process and effectively communicate change strategy to the project team.
• Support external audits including but not limited to Notified Body and FDA audits.
• Maintaining relevant scientific and medical knowledge by attending conferences, courses and meetings.
• Educate internal colleagues across departments and divisions in biological safety evaluations, risk assessments, and chemical characterization.
• Performing due diligence in the selection process of appropriate accredited test labs for test strategy development and test execution.
• Establish contacts and monitor service of the selected vendors.
• Support and lead Project Teams with respect to defining biocompatibility and microbiological testing & validation requirements as deemed required.

What education and experience are required?   
• Minimum of relevant Level 8 Degree in Science/Technology/Engineering.
• Minimum of 7 years’ experience in a quality engineering/ materials/ microbiology role, preferably in the Medical Devices-Industry.
• Experience in interpretation of Analytical techniques including but not limited to, GC, HPLC, IR, Atomic Absorption, & GC-MS.
• Working experience in FDA, MDR, USP, AAMI, ANSI, ASTM, and ISO requirements applicable to biocompatibility, microbiology and quality management system.

What key skills will make you great at the role?  
• Familiarity with regulations and standards published by FDA, USP, MDR, AAMI, ANSI, ASTM, and ISO in the areas of biocompatibility.
• In depth knowledge of ISO 10993 -xx series of Biocompatibility and other related standards such as ISO18562-xx series.
• Knowledge of Microbiological, analytical chemistry and materials science.
• Supplier/Internal Auditing experience.
• Excellent planning, organising, and attention to detail skills, in order to meet deadlines and follow through on assigned deliverables. 
• Strong verbal and written communication skills with an ability to tailor information succinctly to the target audience at all levels of the company. 
• Ability to work within a team environment and work autonomously to achieve agreed company goals.
• Good understanding of ISO 13485, MDR and FDA QSMR quality standards & regulations.
• Strong problem-solving skills, identifying and implementing potential solutions
• Proficiency in the use of desktop software applications such as MS Office.
• Good Knowledge of the application of Statistics (Minitab software or equivalent) and associated numeracy in Chemical calculations. 
  
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 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.

Location
Ireland - Head Office (B1)

Department
R&D

Job Title
Senior Biocompatibility Materials Engineer

Salary

Experience

City
Galway

Country
Ireland