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Configuration Specialist - 56545922 - TT

Job Code: 56545922
Job Location: Arden Hills, MN
Category: Mechanical Engineering
Last Updated: 05/23/2017
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Job Description:
Equipment team. This person will report to the Mechanical Engineering Manager and be responsible for defining, documenting, release and revising assemblies of regulated Class II and Class III medical devices to pre-production and production configurations, as well as performing all administrative and clerical duties for the department. • Coordinate with a variety of engineering staff to define the configuration needed for products
• Prepare change requests to initiate or change product configurations
• Process change requests using the Windchill PDM system
• Make minor document or drawing changes as part of the change process to correct issues or document a new configuration
• Define and update the Bill of Materials (BoM) and document structure
• Participate in change notice meetings
• Monitor the progress of change notices and follow-up to ensure that implemented as specified
• Act as an informed source of company policies and procedures by answering routine questions and/or routing to appropriate employees for answers
• Schedules appointments and travel; maintains up-to-date appointment calendar; ensures that the management team is informed at all times of scheduled commitments and completes expense reports
• Orders office supplies and equipment, and performs or arranges for routine maintenance of basic office equipment
• Composes and/or transcribes routine correspondence, letters, and memos
 
Requirements:
• High school diploma or GED
• Minimum of 2-3 years managing configurations and Bills of Materials (BoMs) for multiple projects
• Able to read and write fluently in English
• Demonstrated experience analyzing and fulfilling documentation requirements as well successfully managing/coordinating a large number of documents for multiple concurrent projects.
• Demonstrated experience analyzing and fulfilling documentation requirements
• Demonstrated experience with change control systems
• Experience working within a quality management system: ISO 13485, Quality System Regulation 21 CFR 820 and Medical Device Directive
• Proficient in Microsoft Office applications
• Detail oriented individual that can strive in a collaborative team environment
Desired Experience/Skills -
• Bachelor’s Degree in Engineering, Business, Information Technology or related science field
• Experience with configuration management
• Experience with medical device Design History Files and Device Master Records in a medical device environment
• Experience with CAD tools such as Pro/Engineer and/or Solidworks
• Experience with product lifecycle management application tools such as Windchill
• Experience in business and/or technical writing
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 56545922TT
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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