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Manufacturing Engineer
Ref No.: 18-64964
Location: Wayland, Massachusetts
Position Type:Contract
Start Date: 09/05/2018
 
Manufacturing Engineer:

JD:
·         5+Yrs experience with product and process Risk assessment, Documentation
·         Understand in-house SOPs related to Manufacturing Process Validation and GDP.
·         Ability to draft work instructions based on review of ongoing process workflows,
·         Hands-on experience working and understanding PFEMA and DFEMA for Medical products
·         Knowledge of ISO 13485, FDA documentation
 
Qualifications:
·         Bachelor's degree in Engineering, Quality Assurance, Mathematics/Statistics or Science Related field required
·         Minimum 5 years of hands-on experience working in the medical device field
·         Experience with the engineering design, analysis, execution and approval of manufacturing IQ, OQ and PQ protocols and reports.
·         Able to effectively communicate validation activity status to all stakeholders
·         Comfortable working with Microsoft Office (MS Word & MS Excel)
·         Comfortable navigating PDF documents using Adobe Acrobat
·         Comfortable working in a cGMP manufacturing floor for 5% of the time and 95% in front of a computer
·         Comfortable writing engineering documents and reports.