Manufacturing Engineer Ii
hace 2 semanas
Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Follow all Good Manufacturing Practices and SOPs as defined by the Company’s polices ensuring that FDA and Quality Standards are met.
- Responsible for executing transfer projects between other Nordson location or customer locations to Nordson Tecate.
- 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 continues 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 within the Tecate facility.
- 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 a part of the Internal Audit team as required.
- Performs other duties as assigned by immediate supervisor.
- Acts as a consultant for areas related to his/her expertise.
- Other duties or projects as assigned.
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:
- 5 to 10 years’ experience required in manufacturing industry, preferably in medical device manufacturing
- Previous technical/engineering management experience.
- Knowledge of molding and/or extrusion process is preferable.
- 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):
- Related experience within 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. Ability to write and comprehend instructions, short correspondence, and memos in both English and Spanish. Interaction with customer is expected in this position.
- Adept at presenting complex topics to customers and management.
- Good medical device engineering and manufacturing experience.
- Able to operate and thrive in a demanding, fast-paced, fluid environment.
- Knowledge in manufacturing statistical analyses including graphical representation of data, statistical process control, process capability, hypothesis testing, and the formulation, execution, and analysis of Designs of Experiments (DOE).
- Good skills in writing and executing engineering studies, validation protocols, final reports, etc.
- Experience in molding process (medical product preferent) and molding equipment (80 to 400 tons)
- Must exhibit good project management, and interpersonal skills, and the ability to balance priorities and workload while working in a team environment.
- COMPUTER SKILLS:
- Proficient in navigation and use of the Windows operating system in a networked environment.
- Solid understanding and ability to use Microsoft Office Tools (Outlook, Word, Excel, Project, Visio, PowerPoint, and SharePoint).
- Proficiency in Minitab.
- Working knowledge of 2D and 3D CAD software including Autodesk AutoCAD, Inventor, and Mechanical Desktop.
- Ability to develop an understanding and practice of Nordson values and competencies.
- Values cultural diversity and other differences; fosters an environment where peopl
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