Manufacturing Engineer II
hace 1 semana
Nordson is seeking a highly skilled Manufacturing Engineer II to join our team in Industrial Precision Solutions and Advanced Technology. As a key member of our organization, you will play a critical role in driving our success by helping us improve and grow, and enabling our customers to succeed.
Key Responsibilities- Ensure compliance with Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) to meet FDA and Quality Standards.
- Lead and coordinate cross-functional teams to define clear goals and objectives for transfer projects between Nordson locations or customer sites.
- Prepare and write technical reports, validation protocols, and technical data to support manufacturing processes.
- Develop and maintain work instructions, and translate documents as needed to meet Quality System requirements.
- Apply Lean Manufacturing, Six Sigma, and Theory of Constraints methodologies to drive improvements in manufacturing costs, efficiencies, and lead times.
- Interact with manufacturing lead persons, supervisors, and managers to identify and resolve manufacturing deficiencies.
- Manage and execute Environmental, Health, and Safety (EHS) projects and regulatory activities within the Tecate facility.
- Establish and utilize project management tools to manage projects and provide weekly and monthly report outs.
- Maintain and update the Tecate facility layout to optimize manufacturing processes.
- Prioritize and manage new product prototyping.
- Participate in internal audits and assist as a consultant for areas related to expertise.
- Bachelor's degree in engineering or a related technical field.
- 5-7 years of experience in manufacturing, preferably in medical device manufacturing.
- Previous technical or engineering management experience.
- Knowledge of molding and/or extrusion processes is preferred.
- Experience in advanced engineering and statistical problem-solving methods, including Six Sigma training.
- Related experience in international standards (ISO 13485/9001), FDA, and European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA, and PFMEA).
- Well-developed written and verbal communication skills in English and Spanish.
- Able to write and comprehend instructions, short correspondence, and memos in both English and Spanish.
- Proficient in Microsoft Office Tools (Outlook, Word, Excel, Project, Visio, PowerPoint, and SharePoint).
- Working knowledge of 2D and 3D CAD software, including Autodesk AutoCAD, Inventor, and Mechanical Desktop.
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