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Manufacturing Engineer (Process Development)
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?
This role presents a great opportunity to work within an Aerogen process development team to develop, improve and implement manufacturing processes used to manufacture Class II respiratory products. The role will support the process development through the entire design cycle from initial concept to commercial production. In all cases the role is expected to challenge and improve NPD Manufacturing systems as enablers to advance project execution.
What are the key responsibilities?
• Work within team environment to develop and introduce new manufacturing processes.
• Identify and implement process improvement opportunities through data analysis to include improved quality, increased capacity/service, and product cost.
• Lead project teams or working as part of an overall project team on specific assignment objectives. Project Scope out with due regard to objectives, need, cost, risk, schedule, and resource management. Determine key inputs for project approval, responsibilities, and critical path activities.
• Complete relevant documentation required as part of a process development project, including process characterisation, validation protocols, reports, change control procedures, and manufacturing instructions etc.
• Troubleshooting of equipment and process issues utilizing lean troubleshooting, preventative maintenance, and design methodologies.
• Prepare technical documentation in clear and concise terms in accordance with good engineering practice. Be prepared to represent such documentation in an audit by customers or regulatory authority.
• Liaise closely with and communicate effectively to the R&D, manufacturing, operations, quality, sales and marketing functions through the product development lifecycle.
• Mentor and be responsible for activities and training of other team members.
• Be involved in making improvements to the way the team operates as well as the tools, procedures and templates they use.
What education and experience are required?
• Level 8 qualification in Engineering, Technology or Science with a minimum of 4 years experience.
or
• Level 7 qualification in Engineering, Technology or Science along with a Trade certificate and minimum 6 years relevant experience.
• Minimum 2+ years’ experience in the Medical Device / Regulated Industries would be a distinct advantage.
What key skills will make you great at the role?
• Experience working in medical device manufacturing, maintaining and improving processes.
• Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes.
• Good understanding of EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements as these apply to this role.
• Very strong organizational, project management and co-ordination skills.
• Meticulous attention to detail with a methodical and analytical approach to problem solving.
• Data analysis and numeric skills with the ability to evaluate, analyse and present data.
• Highly motivated self-starter and be able to work in a dynamic environment with little supervision or daily direction.
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.
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?
This role presents a great opportunity to work within an Aerogen process development team to develop, improve and implement manufacturing processes used to manufacture Class II respiratory products. The role will support the process development through the entire design cycle from initial concept to commercial production. In all cases the role is expected to challenge and improve NPD Manufacturing systems as enablers to advance project execution.
What are the key responsibilities?
• Work within team environment to develop and introduce new manufacturing processes.
• Identify and implement process improvement opportunities through data analysis to include improved quality, increased capacity/service, and product cost.
• Lead project teams or working as part of an overall project team on specific assignment objectives. Project Scope out with due regard to objectives, need, cost, risk, schedule, and resource management. Determine key inputs for project approval, responsibilities, and critical path activities.
• Complete relevant documentation required as part of a process development project, including process characterisation, validation protocols, reports, change control procedures, and manufacturing instructions etc.
• Troubleshooting of equipment and process issues utilizing lean troubleshooting, preventative maintenance, and design methodologies.
• Prepare technical documentation in clear and concise terms in accordance with good engineering practice. Be prepared to represent such documentation in an audit by customers or regulatory authority.
• Liaise closely with and communicate effectively to the R&D, manufacturing, operations, quality, sales and marketing functions through the product development lifecycle.
• Mentor and be responsible for activities and training of other team members.
• Be involved in making improvements to the way the team operates as well as the tools, procedures and templates they use.
What education and experience are required?
• Level 8 qualification in Engineering, Technology or Science with a minimum of 4 years experience.
or
• Level 7 qualification in Engineering, Technology or Science along with a Trade certificate and minimum 6 years relevant experience.
• Minimum 2+ years’ experience in the Medical Device / Regulated Industries would be a distinct advantage.
What key skills will make you great at the role?
• Experience working in medical device manufacturing, maintaining and improving processes.
• Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes.
• Good understanding of EN ISO 13485:2016, EU-MDR, MDSAP and FDA requirements as these apply to this role.
• Very strong organizational, project management and co-ordination skills.
• Meticulous attention to detail with a methodical and analytical approach to problem solving.
• Data analysis and numeric skills with the ability to evaluate, analyse and present data.
• Highly motivated self-starter and be able to work in a dynamic environment with little supervision or daily direction.
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 - Shannon
Ireland - Shannon
Department
Engineering
Engineering
Job Title
Manufacturing Engineer (Process Development)
Manufacturing Engineer (Process Development)
Salary
Experience
City
Clare
Clare
Country
Ireland
Ireland
