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Manufacturing Engineer (Moulding)
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 Manufacturing Engineer is responsible for providing engineering support to existing and new processes to meet Quality, Service and Cost Objectives at the Aerogen Shannon Manufacturing facility.
What are the key responsibilities?
• Provide subject matter expertise on Aerogen’s process technologies to support key business metrics.
• Support and deliver process and equipment validations including URS, FAT, SAT, IQ, OQ, PQ, protocol development, implementation, and report completion to timelines.
• Design, generate and deliver test plans and test protocols ensuring validation documentation is fully compliant with site specific policies/procedures and regulations, good manufacturing practices and industry regulations.
• Responsible for reporting on yield, OEE metrics and product failure investigation.
• Monitor manufacturing activities, measure significant process characteristics, and analyze variation to detect and reduce waste/scrap, assist the manufacturing processes by taking corrective and preventative actions on production delays and deviations. Use Lean methodologies to drive continuous improvement focused on Quality, Cost, Material flow and layout.
• Manage change through the change control process responsible for controlling the lifecycle of all changes within the QMS system.
• Lead or actively participate in cross-functional teams to ensure that continuous improvement projects are completed in a timely and efficient manner.
• Ensure effective closure of Quality System documents (Audit Actions, NC’s, CAPA’s, etc.).
• Ensure Health and Safety Regulations and Procedure are adhered to at all times for self and others.
• Support all customers, FDA and NSAI audits when required.
• Assist, as necessary, other functions to achieve timely product shipments.
What education and experience are required?
• Diploma in Mechanical or Polymer Engineering, Technology or Science, or an equivalent qualification
• 4 years’ experience within ISO13485 registered medical device industry with injection moulding experience.
• Experience in high-speed automated assembly is essential for this role.
• Knowledge of Medical Grade ABS Injection Moulding in combination with cavity pressure sensing, hot runner systems, automatic part extraction pick & place systems would be advantageous
What key skills will make you great at the role?
• Excellent understanding of EN ISO 13485:2016, MDSAP and FDA requirements.
• Strong understanding of polymer processing
• Being very familiar with IQ, DOE, OQ, & PQ in terms of drafting, and delivering.
• Strong team member with the ability to identify and drive implementation of innovative quality improvements.
• Meticulous attention to detail while also conveying a sense of urgency.
• Effective communication and interpersonal skills; written, verbal and presentation. Must have the ability to communicate effectively and concisely at all levels of the company.
• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
• Ability to lead Project Teams and proactively contribute to continuous improvement initiatives.
• Strong problem-solving capability, possessing a demonstrated capacity to identify problem root causes, deliver solutions, risk assessment.
• Data analysis and numeric skills with the ability to evaluate, analyse and present data.
• Ability to create, plan and coordinate changes to product and process with cross functional teams, vendors, and customers.
• Work closely with Quality, Production and Supply Chain departments to establish and identify the conditions that underpin reliable equipment and Manufacturing Processes.
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 firstname.lastname@example.org. Please include your name and preferred method of contact.
Ireland - Shannon
Manufacturing Engineer (Moulding)