The key responsibilitiesand /or task of the Manufacturing Engineer II consist of transfer projects (new processand/or products), improving the current manufacturing process (yield,productivity and on time delivery), and support to Operations activities. ESSENTIAL DUTIES & RESPONSIBILITIES Follow all Good Manufacturing Practices and SOPs as defined by the Company’s policies ensuring that FDA and Quality Standards are met. Responsible for executing transfer projects. Leads and coordinates a cross-functional team (supply chain, quality, and manufacturing departments) to define clear goals and objectives as well as set the appropriate conditions for each transfer project. Prepare and write technical reports and technical data such as validation protocols, qualification test procedures, acceptance test procedures, reports, component maintenance manuals, etc. Creating/updating work instructions as well as translation of these documents as needed within the Company’s Quality System requirements. Key member of the continuous improvement team applying Theory of Constraints, Six Sigma, and Lean Manufacturing methodologies as tools to drive improvements in manufacturing costs, efficiencies, and lead-times. Interact with manufacturing lead persons, supervisors and managers as needed to identify, and resolve/ improve manufacturing deficiencies. Responsible for managing and execution of EHS (Environmental, Health and Safety) projects and/or regulatory activities. Establish and utilize project management tools to manage projects with appropriate weekly & monthly report outs and escalation of significant issues when required. Responsible for maintaining/modifying and updating the Tecate facility layout. Prioritize and manage all new product prototyping. Participate and assist as part of the Internal Audit team as required. Acts as a consultant for areas related to his/her expertise. Ability to develop an understanding and practice of Nordson values and competencies. MINIMUM QUALIFICATIONS To perform this position successfully, an individual must be able to perform each job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. REQUIRED EDUCATION Bachelor’s degree in engineering or related technical field REQUIRED LENGTH & TYPE OF EXPERIENCE Minimum 7 years’ experience required in manufacturing industry, preferably in medical device manufacturing Previous technical/engineering management experience. Experience in advanced engineering & statistical problem-solving methods is desired, including Six Sigma training. Six Sigma Green Belt or Black Belt certification is desired. KNOWLEDGE, SKILLS & ABILITIES (KSA’s) Knowledge of ISO 13485:2003, GMP, FDA, QSR. European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA and PFMEA) Understanding of common machine shop practices, fixture design and assembly techniques. Well-developed written and verbal communication skills in English and Spanish. Ability to write and comprehend instructions, short correspondence, and memos in both English and Spanish. Interaction with customer is expected in this position. Must exhibit good project management, interpersonal skills, and the ability to balance priorities and workload while working in a team environment. #J-18808-Ljbffr