• Manufacturing Engineer II, Investigations

    Job Locations US-MA-Bedford
    Posted Date 6 months ago(12/22/2017 8:51 AM)
    Job ID
    2017-1036
    # of Openings
    1
    Category
    Operations
  • Overview

    The Manufacturing Engineer II shall support diverse commercial product and new product development projects for medical device and pharmaceutical products, the manufacturing organization, and all facility related engineering projects and ongoing maintenance. Lead cross-functional teams to resolve issues that may arise during manufacturing, such as deviations and investigations, and implementation of solutions.

     

    Responsibilities

    •Responsibilities include change control ownership, leading C&Q activities, root cause investigations, and corrective actions 
    •Operations lead for Quality Events and Material Review Board meetings
    •Leads cross-functional teams for manufacturing trending and continuous process improvements
    •Generate, review and approve internal operating procedures and specifications
    •Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required
    •Assist in the development and implementation of manufacturing processes for complex product development projects for medical device and/or pharmaceutical products
    •Demonstrates good judgment in selecting methods and techniques for obtaining solutions
    •Networks with senior internal and external personnel in own area of expertise

    Qualifications

    •BS in Engineering, preferably Chemical or Mechanical
    •Minimum of 4 years’ experience in manufacturing or product development in the pharmaceutical industry
    •Six Sigma qualification preferred
    •Modeling software preferred
    •Familiar with ISO 9000/ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
    •Experience with statistical analysis of data
    •Ability to work with mechanical equipment and lift up to 30 lbs.
    •Must be able to work in both cleanroom and chemical laboratory environments

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