Manufacturing Engineer II
Job Summary:
Aerogen seeks a Manufacturing Engineer II to drive product, process, and sustainability improvement projects. This role offers the opportunity to identify and implement creative solutions using data analytics and problem-solving capabilities.
Key Responsibilities:
* Support project scoping, planning, and approval with due regard to objectives, need, costs, risks, schedule, and resource management.
* Lead and contribute to cross-functional Quality, Sustainability, and Cost Improvement projects from initiation to final delivery.
* Participate in supplier selection process through risk assessment and approval of new vendors for dual source or new component supply.
* Support Process Development, Product Development, and Process Engineering projects through Design Review process.
* Perform other assigned tasks as directed by Supervisor or Head of Function.
Requirements:
* Level 8 qualification in Engineering, Technology, or Science.
* A minimum of 3 years' relevant experience.
* Technical Experience: Knowledge of design verification and process validation frameworks, with focus on equipment/manufacturing processes.
* Strong Problem-Solving capability: Knowledge and experience of root cause analysis techniques and application of problem-solving methodologies.
* Data analysis: Generates and analyzes data and presents findings in a logical, actionable way.
* Project Planning: Executes and manages project deliverables by planning, monitoring, adjusting, and communicating project activities.
* Organisation: Strong organisational skills with meticulous attention to detail.
* Collaboration: Effective communication and interpersonal skills; written, verbal, and presentation.
* Leadership: Excellent leadership skills with demonstrated decision-making ability.
* Experience working in medical device manufacturing and maintaining/enhancing processes with good understanding of EN ISO 13485:2016, EU.
* Proficiency in Microsoft Office software.