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 manufacturingpractices and sops as defined by the company’s polices ensuring that fda andquality standards are met.
* responsible for executingtransfer projects.
* leads and coordinates a crossfunctional team (supply chain, quality, and manufacturing departments) todefine clear goals and objectives as well as set the appropriate conditions foreach transfer project.
* prepare and write technicalreports and technical data such as validation protocols, qualification testprocedures, acceptance test procedures, reports, component maintenance manuals,etc.
* creating/updating workinstructions as well as translation of these documents as needed within thecompany’s quality system requirements.
* key member of the continuesimprovement team applying; theory of constraints, six sigma, and leanmanufacturing methodologies as tools to drive improvements in manufacturingcosts, efficiencies, and lead-times.
* interact with manufacturing leadpersons, supervisors and managers as needed to identify, and resolve/ improve
* manufacturing deficiencies.
* responsible for managing andexecution of ehs (environmental, health and safety) projects and/or regulatoryactivities.
* establish and utilize projectmanagement tools to manage projects with appropriate weekly & monthlyreport outs and escalation of significant issues when required.
* responsible for maintaining/modifying and updating the tecate facility layout.
* prioritize and manage all newproduct prototyping.
* participate and assist as a partof the internal audit team as required.
* acts as a consultant for areasrelated to his/her expertise.
* ability to develop an understanding andpractice of nordson values and competencies.
minimum qualifications:
to performthis position successfully, an individual must be able to perform each job dutysatisfactorily. The requirements listedbelow are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made toenable 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
* previoustechnical/engineering management experience.
* experience inadvanced engineering & statistical problem-solving methods is desired,including six sigma training. Six sigmagreen belt or black belt certification is desired.
knowledge, skills &abilities (ksa’s):
* knowledge of iso 13485:2003, gmp,fda, qsr.european quality systemsrequirements (qsr, mdd), and risk management (iso 14971, dfmea and pfmea)
* understanding of common machineshop practices, fixture design and assembly techniques.
* well-developedwritten and verbal communication skills in english and spanish. Ability towrite and comprehend instructions, short correspondence, and memos in bothenglish and spanish. Interaction withcustomer is expected in this position.
* must exhibit good project management, and interpersonal skills, and the ability to balance priorities and workload while working in a team environment
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