About Aerogen
We are a world leader in acute care aerosol drug delivery, recognized through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America. Our employees make a difference to patients' lives every day, having already reached 20 million patients in over 80 countries.
Senior Operational Excellence Engineer I Role
This role is responsible for achieving operational excellence in all areas of production, process development, process and space optimization, capacity expansion, quality improvements, cost reduction and developing a high performing lean culture.
Key Responsibilities:
* Implement lean principles in the production environment, including Customer first, Strategy Alignment, Go See, Flow & Pull, Focus on Process, Build in Quality, People Engagement, and creating Value Improvement.
* Facilitate and encourage the production team in the use of lean tools, such as Fishbone, 5 Whys, Is/Is Not, A3s, DMAIC, PDCA, 3c's, 5S, SMED standard work, to enable a culture of waste reduction and continuous Improvement.
* Facilitate lean principles to direct team members, including 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 Indictors (KBIs).
* Effectively communicate and present project updates at all levels of the organization, 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.
* Ensure that 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.
* Collaborate 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 of 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. Black belt in Lean six sigma an advantage.
Desirable Skills:
* Lifelong learning desire.
* 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 organizational and Project Management Skills.
* Knowledge of Design Verification and Process Validations, particularly as it pertains to equipment and manufacturing processes.
* Excellent planning, organizing and communication skills.
* Able to work effectively as part of a multi-functional team.
* Able to manage complex problem solving and cost/capacity improvement projects with cross functional teams.
* Able to present ideas and concepts clearly and effectively.
* Familiar and comfortable with standard medical device documentation.
* Able to grasp and statistically scrutinize data.
* Able 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.