FPC National

Nationwide Executive Recruitment From FPC

(F-O-R-T-U-N-E PERSONNEL CONSULTANTS)

You'll Value The Experience!

 

Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. Executes the functional deliverables associated with  Project Management, and Quality Systems. Plans, organizes, and conducts all aspects of technical reviews. Ensures proper documentation is completed to meet quality systems requirements.   Writes and reviews validation protocols and reports applicable to new processes. Oversees development builds associated with the project using special work requests. Develops qualified production lines. Provides Design for Manufacturability (DFM) input to the engineering print package. Contributes ideas to or generates Intellectual Property submissions. Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation. May serve as a core team member or extended team member on new product projects.

Leads and/or participates on project teams coordinating the efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve product, equipment, and fixture processes. Performs engineering work typically including one of the following: process/product improvements, test of materials, preparation of specifications, process study, evaluation of process models/process improvements, product design, development improvement of equipment, tools, fixtures, report preparation, and other activities of wide scope requiring broad knowledge of precedents in medical device design and development and good knowledge of principles and practices of related specialties. Interfaces with vendors and other outside specialists. Audit, investigate, test, and evaluate external process technologies. Applies Six Sigma skills to reduce cost and improve yields.


Qualifications:
 BS Mechanical or Electrical Engineering

 

A minimum of 3-5 years experience in an FDA regulated manufacturing environment required. 

 

Proven Six Sigma / DOE/ and Process Validation skills.

 

Proficiency with Medical Device development life cycles and manufacturing processes and technologies preferred.

 

 

 

Knowledge of JIT and/or Lean Flow Manufacturing helpful. Knowledge of materials/ plastics helpful.

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