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Senior Manufacturing Engineer

Company: Nordson Corporation
Location: Huntington Beach
Posted on: June 6, 2021

Job Description:

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.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart. Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.

Essential Job Duties and Responsibilities

  • Develop manufacturing capabilities and processes to build and test new products.
  • Interact with product engineers, manufacturing personnel, and management regularly to identify and understand opportunities to improve manufacturing processes and product design (design for manufacturability).
  • Understand manufacturing tolerances and capabilities to complete design for manufacturability studies. Provide mentorship to support and train less experienced engineers in this area.
  • Design and develop tooling, fixtures, hand tools, and small equipment as required to support the manufacture of new products or as a part of continuous improvement projects.
  • Modify, validate/verify, and release tooling, fixtures, lower level assembly drawings and specifications as required.
  • Participate in cost estimating activities to develop costing for new product proposals.
  • Lead engineering studies and analyses on existing manufacturing processes to improve product quality, delivery performance, productivity, and cost.
  • Create manufacturing plans, process line layouts, operator balance charts, and detailed manufacturing work instructions (standard work).
  • Create all manufacturing documentation as required including Build Packets, Bill of Materials, Manufacturing Assembly Processes, Process Instructions, PFMEAs, etc.
  • Develop validation strategies and write Master Validation Protocols (MVP). Plan, create, and execute engineering studies and validation protocols (IQ, OQ, PQ) and final reports.
  • Develop and analyze production capacities.
  • Lead cross-functional / cross-facility teams to plan and complete manufacturing scale-up of new products per project commitment dates.
  • Actively participate with equipment development team in the design of next generation or new equipment.
  • Provide support to the sustaining engineering group to resolve manufacturing technical issues in the factory.
  • Evaluate proposed changes, assess feasibility, make approve/reject recommendation, and implement customer requested changes via the Engineering Change Review (ECR) system.
  • Complete non-conformance investigations using root-cause analysis tools and develop corrective/preventative actions to address customer complaints, CAPA's and NCMR's.
  • Follow all company and regulatory policies and procedures including but not limited to FDA, ISO, QSR, GMP, OSHA, and/or other applicable standards and regulations to ensure compliance.
  • Participate and assist as a part of the Internal Audit team as required.
  • Communicate ideas and information clearly, effectively, and frequently (oral and written) within the Avalon project team.
  • Advanced user and trainer in the use of statistical tools to analyze data and make decisions.
  • Performs other duties as assigned in support of department, site, and company goals & objectives.

Education and Experience Requirements

  • Bachelor's degree in engineering or related technical field.
  • Minimum of 5 years manufacturing engineering experience in medical device manufacturing
  • Experience in advanced engineering & statistical problem solving methods. Six Sigma Green Belt or Black Belt certification is highly valued.
  • Understanding of common machine shop practices, fixture design and assembly techniques.
  • Related experience within international standards (ISO 13485 / 9001), FDA and European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA and PFMEA).

Skills and Abilities

  • Strong medical device design engineering and manufacturing experience
  • Substantial knowledge and experience of various manufacturing processes including: polymer processes such as dip molding, extrusion, injection molding, over-molding, and plastic joining technologies, as well as prototyping, precision machining, assembly, and packaging.
  • Significant knowledge of polymer material properties and the practical application of these principles in establishing robust manufacturing processes, troubleshooting processes, and consulting with customers on material selection.
  • Must be able to apply engineering concepts, original thinking, cause and effect, and ingenuity to solve problems. This includes the design, development and testing of tooling, fixtures, and manufacturing & assembly processes.
  • Excellent project management capabilities, establishing timelines, predicting risks and developing mitigation plans.
  • Robust critical thinking skills with the capability to quickly dissect situations and solve problems.
  • Proficient in statistical analyses including graphical representation of data, hypothesis testing, and the formulation, execution, and analysis of Designs of Experiments (DOE).
  • Excellent verbal and written communication skills. Capable of explaining complex topics to others.
  • Strong skills in planning and executing engineering studies, verification & validation protocols, final reports, etc.
  • High proficiency in the use of tools, and ability to lead continuous improvement projects using Theory of Constraints, Six Sigma, and Lean Manufacturing concepts.
  • Training and practical experience in applying Design for Six Sigma is preferred.
  • Must exhibit good interpersonal skills, and the ability to manage his/her own priorities and workload while working in a team environment.
  • Willing and able to travel to Mexico as required
  • Spanish as second language highly valued

COMPUTER SKILLS:

  • Proficient in navigation and use of the Windows operating system in a networked environment.
  • Strong understanding and ability to use Microsoft Office Tools (Outlook, Word, Excel, Project, Visio, PowerPoint, and SharePoint).
  • Functional knowledge of Minitab
  • Knowledge of 2D and 3D CAD software including Autodesk AutoCAD, Inventor, and Mechanical Desktop.
  • Proficient user of Minitab.

Working Conditions and Physical Demands

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Travel Required

Estimated _10%

Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

Keywords: Nordson Corporation, Huntington Beach , Senior Manufacturing Engineer, Other , Huntington Beach, California

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