Associate Process Development Engineer

Position Summary

The Associate Process Engineer will support, maintain and upgrade new and existing production processes and machinery, by interfacing with engineering product development, quality engineering, manufacturing personnel, control engineers, product engineers, draftspersons, lab technicians, and outside vendors. In addition, lead the identification and development of next generation processes related to medical device manufacturing.

Principal Responsibilities

•    Support and upgrade production processes, including pad printing, general assembly, molding, extrusion, and catheter tipping. Support includes hands-on tooling and resin preparation, machine setup and execution of experiments in an engineering lab environment.
•    Develop robust and capable processes for new and existing manufactured products. Document, validate and determine standards for developed processes. 
•    Plan, Develop, and Execute Process and Test Method Validations (IQ, OQ, PQ, and TMV) in accordance with Teleflex procedures.
•    Prepare or review documentation with a high degree of accuracy, completeness, and effectiveness using engineering tools and templates where available (i.e. validation documents, specifications, manufacturing procedures, ECOs, and technical reports or analysis summaries). 
•    Apply DMAIC - Six Sigma approaches to solve issues and reduce variation in all manufacturing processes. 
•    Consult with engineers, technicians, drafts people, and manufacturing personnel regarding machine design, process/product design, tooling/fixturing and production issues. 
•    Interact with outside vendors to investigate commercial machine and equipment applications to upgrade Teleflex manufacturing capabilities and technology.
•    Interface with product engineering to design and develop new or modified products. 
•    Coordinate, specify, build, validate/revalidate, and troubleshoot machinery. 
•    Work on projects critical to business needs. Participate in project technical reviews for new product development. 
•    Lead manufacturing transfer of new processes, including process updates and new processes accompanying new product development.
•    Train personnel such as other engineers and technicians in the use of new equipment, processes and documentation. 
•    Design and execute process capability studies for developed processes using statistical analysis tools within Minitab Statistical Software (Capability Analysis, Tolerance Intervals, Probability Plots, Control Charts, etc.)
•    Participate in failure mode and effects analysis (FMEA) to ensure production processes have mitigations in place to ensure product quality. 
•    Perform root cause analysis (RCA) related to product and process issues. Participate in NC and CAPA investigation phases using common assessment tools (Fish Bone Diagrams, 5-Whys, Pareto Charts, Fault Trees, etc.)
•    Travel to manufacturing facilities for implementation and transfer of manufacturing processes.   
•    Adhere to and ensure the compliance of Teleflex's Code of Ethics and all company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    AS in Engineering, or equivalent (Biomedical, Mechanical or Polymer Engineering); BS preferred.
•    Minimum of 1-2 years of previous experience in related field (e.g. medical device manufacturing & assembly, plastics, automation) that may include hands-on experience in an academic environment
 

Specialized Skills / Other Requirements

•    Preferred medical device manufacturing and experience including transferring products from design to manufacturing.
•    Must have demonstrated ability and experience to balance and multi-task multiple engineering projects and programs in support of internal customers. 
•    Understanding of polymer materials properties and the practical application of these principles in establishing robust manufacturing processes, troubleshooting.
•    Must have working knowledge of Microsoft Office, Minitab & SolidWorks
•    Must be able to apply engineering concepts, original thinking, cause and effect, and ingenuity to solve problems. 
•    Must be able to apply statistical analysis to determine process capabilities, compare populations via hypothesis testing, utilize process control charting, and use the output of these analysis to improve operations. 
•    Knowledge and experience in designing and performing Design of Experiments (DOE) desirable.
 

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