Senior Operational Excellence Engineer I
About Aerogen:
Aerogen is the world leader in acute care aerosol drug delivery, headquartered in Galway with offices worldwide.
We are a recognised MedTech awards winner and eight-time Zenith award winner for Respiratory Care Excellence in North America.
Our employees make a difference to patients' lives every day, having reached 20 million patients in over 80 countries.
We collaborate to innovate, challenge, and test not only 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.
What is the role?
The Senior Operational Excellence Engineer I is responsible for achieving operational excellence in all areas of production, process development, process and space optimisation, capacity expansion, quality improvements, cost reduction, and developing a high-performing lean culture.
They will implement and educate the team on lean tools within a fast-paced medical device manufacturing environment.
Key Responsibilities:
* Implement lean principles in the production environment.
* Facilitate and encourage the production team in the use of lean tools.
* Facilitate lean principles to both direct team members and cross-functional personnel.
* Maintain and improve key performance metrics and implement visual management of same.
* Drive continuous improvement of key performance indicators (KPIs) and key behavioural indicators (KBIs).
* Effectively communicate and present project updates at all levels of the organisation engaging all relevant stakeholders.
* Act as a 'Change Agent' in the introduction of Lean Tools in manufacturing and drive/sustain improvements by working directly with Teams at cell/line level.
* Control the layout and optimisation of production and packaging lines.
* Evaluate if all work is produced to the standard required by the business and all relevant regulatory bodies.
* Re-engineer procedures and work practices to streamline manufacturing activities while maintaining compliance.
* Identify and implement methodologies that sustain gains.
* Benchmark with other industries who are implementing Business or Operational Excellence.
* Become involved in all sites Operational Excellence process and identify synergies and common ground between the Parkmore, Shannon, and Dangan Sites.
* Define standard times and engineer standards, collaborating with production to spotlight and action improvement opportunities.
Requirements:
* Minimum of a primary degree in Industrial Engineering/Engineering or technological discipline.
* Minimum of 5-7 year experience in a medical process development or manufacturing environment.
* 2-4 years' experience with defining and executing continuous improvement initiatives.
* Relevant experience of continuous improvement with minimum of green belt lean six sigma training. A black belt in Lean six sigma an advantage.
Key Skills:
* A desire for lifelong learning.
* Knowledge of layouts, labelling, and packaging an advantage.
* Meticulous attention to detail with a methodical and analytical approach with excellent problem-solving tool skillsets.
* Very strong organisational and Project Management Skills.
* Knowledge of Design Verification and Process Validations, particularly as it pertains to equipment and manufacturing processes.
* Excellent planning, organising, and communication skills.
* Ability to work effectively as part of a multi-functional team is a key requirement.
* Ability to manage complex problem solving and cost/capacity improvement projects with cross-functional teams.
* Ability to present ideas and concepts clearly and effectively.
* Familiar and comfortable with standard medical device documentation.
* Ability to grasp and statistically scrutinise data.
* Ability to engage with all stakeholders.
* Highly motivated self-starter with an innovative mindset.
* Understanding of ISO 13485 and FDA Design and Development Processes.
Working at Aerogen:
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.
Benefits:
* 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.