Validation Engineer

Date: Feb 11, 2021

Location: Arlington Heights, IL, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3410

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Under supervision, supports the professional members of the team responsible for engineering and manufacturing; provides processing support to manufacturing for products, assemblies, blow, fill, seal processes, packaging processes, and supporting utilities; performs engineering duties to set up engineering tests, studies, and validations; assists the engineers with tests and evaluations; recommends improvements to manufacturing procedures through submittal of EO; develops and writes procedures;  performs other related duties as required.

Principal Responsibilities

This position is distinguished from Senior Manufacturing Engineering Technician by the ability to perform a full range of assigned duties including complex studies and projects requiring analysis, extensive research, and development of unusual or original solutions. The primary function of this position is to develop, prepare, write and run protocols, and related engineering studies.  Employees at this level receive direction only and occasional instruction or assistance as new or unusual situations arise, and are fully aware of the operating procedures and policies.

ESSENTIAL FUNCTIONS

  • Develop, set up, write, and run Validations
  • Evaluate the processes and equipment utilized to manufacture products
  • Provides technical expertise to the manufacturing floor in the areas of root cause analysis, troubleshooting, process problem solving, risk analysis, statistical analysis, and process improvements
  • Researches and solves related process and material problems as necessary
  • Develops product specifications, process steps, diagrams, protocols, procedures, forms, Engineering Orders, drawings, and other documents related to manufacturing processes
  • Develops cost reduction programs to achieve corporate goals
  • Prepares/collects data to ensure BOM accuracy
  • Provides sample documentation, reviews results, and issue specifications
  • Set up test studies as needed and conducts the evaluation of products produced
  • Ensures products are produced to specifications; writes operating procedure changes to improve the production process as necessary

MARGINAL FUNCTIONS

  • Enhances growth and development through participation in education programs, current literature, training meetings, and workshops
  • Maintain a personal program of self-development to stay current in the technology, regulatory, and practices of manufacturing
  • Participates actively in continuous quality improvement activities through compliance with standards and procedures
  • Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintains good employee relations, interdepartmental objectives, and departmental goals and objectives
  • Maintains compliance with principles of accepted employee conduct as identified in the Teleflex Medical Hudson RCI employee handbook and as specified in department specific policies and procedures
  • Performs other duties as assigned or requested 
     

Education / Experience Requirements

Education:

  • Candidate will have graduated from an accredited college with a Bachelor Degree and/or Associate Degree in Engineering, Science, Quality Systems, and/or Industrial Manufacturing Technology.
  • The equivalent in practical work experience, specialized training and additional qualifying experiences may be substituted for required education

Experience:

  • Minimum of 2 - 5 years equipment validation related experience, preferably in the medical manufacturing industry.

Specialized Skills / Other Requirements

•    GMP and related requirements for sterile blow, fill, seal operation and assembly of critical medical components and device

•    Knowledgeable of FDA, USP, ISO, EU, OSHA, EPA regulations

•    Understanding of the principles and practices of processing equipment 

•    Working knowledge of sterile processing equipment operation 

•    Understanding of the function of critical supporting utilities

•    Knowledge of plastic materials, additives, films, and dyes

•    Knowledge of packaging and labeling operations

•    Knowledge of Quality and Manufacturing Systems, CAPA, NR, SAP, SPC, RA 

•    Knowledge of manufacturing and packaging procedures

•    Understanding of Lab Testing Practices and Calibration Requirements

•    Understanding of principles of manufacturing processes to properly setup an efficient operation of production systems

•    Office skills including computer functions/applications’ MS Word, Excel, Projects, Access, Power Point, Outlook, and Visio

•    Basic understanding of CAD

•    Understanding of research methods including technical writing skill to develop reports
 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Chicago