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Saturday, 27 August 2011

Mid-Level Manufacturing Process Engineer

Staff Orange is looking for Mid-Level Manufacturing Process Engineer
Title:  Mid-Level Manufacturing Process Engineer  (3 - 5 Years Industry Experience)
Location:   Plymouth , MN “Locals Only”
Duration :  6 Months
Job Duties :
-Design of Experiments (DOE) and Statistical Process Control (SPC)
-Determines manufacturing operation requirements and process parameters
-Develops plans to evaluate process repeatability and stability
-Participates in procedure writing and review
-Performs process and equipment validations
-Ensures compliance with GMP's
-Generates documentation for engineering protocols and reports
-Writes engineering and manufacturing specifications
Skill Sets:
Required:
Desired:
Education Level:
Graduate Degree
High School Diploma or Equivalent
Written Communication:
Good
Industry Experience:
Greater than 5 Years
Request Notes : 
Position Description:
-6 to 9 month assignment to help support and qualify manufacturing equipment and processes to produce a high quality product at optimal cost.

-Acts under general supervision of Value Steam Manager and other senior engineers on multiple assignments of complex nature and wide scope
Position Responsibilities
.Protocol writing and execution of IQ (Installation Qualifications) OQ (Operation Qualifications and PQ (Performance Qualifications

.Defines and generates all required documentation in support of manufacturing products and processes. These include: Engineering protocols, FMEAs, reports, manufacturing instructions and procedures.

-Ensures compliance with GMP's and internal MDT protocols.

-Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations.

.Develop and Optimize Work Design, Manufacturing Layout and Product Flow

-Recommends and implements process layouts using lean manufacturing philosophies for increased efficiency in manufacturing.

-Recommends appropriate staffing level to support manufacturing requirements.


Basic Qualifications

.Bachelor's - Mechanical Engineering or related field

.5-7 years increasing complex responsibilities as a Manufacturing Engineer in an environment of continuous improvement

.Must be well experienced in qualification and validation protocols in a medical environment

.Must have medical device experience

.Self starter with the ability to lead projects to completion

.Continuous Improvement Philosophies

.Working knowledge of medical device materials and related processes

.Statistical methods: DOE, SPC, FMEA

.Understanding of product/process test equipment

.Ability to work in team environment

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