Sr. Manufacturing Engineer

 Job Description & Skill Requirement:

 

 Responsibilities:
•    Background from Quality Mazaak i200 and EMC Oven Machaine Validation
Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and validation related activities. 
•    Need to have familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in titanium machining process and product quality 
•    Provides technical input for projects using the application of FMEA’s, risk mitigation, plant validations; DOE’s’ and other experiments and investigations as assigned.
•    Working knowledge of Validations, IQ, OQ, PQ, SIMS and DOE's is desirable.
•    Should possess good knowledge in Machining process and its defect remediation activities.
•    Should have good understanding and experience in GD&T and complex drawing interpretation.
•    Should have hands on experience in creating PFMEA and Process control plans.
•    Should operate autonomously to review vendor documents, identify gaps and work with to close the gaps. Approve and assist in Launch of products.
•    Co-ordinate with Vendor to complete the PPAP documentation.
•    Should have sound experience in Non – conformance identification, RCA, CAPA and implementation from medical device manufacturing background.
•    Proven track record of supporting and driving continuous improvement activities in a production environment.

 

Qualification:

• Bachelor’s degree  preferably Manufacturing, Industrial Engineering

 

Skills:

• Bachelor’s degree in science, engineering, or manufacturing discipline
• Experience in ISO-13485 certified and cGMP organizations preferred. Medical device manufacturing,
• Background from Quality Mazaak i200 and EMC Oven Machine Validation
• 10-13  Years experience to lead and drive  Incoming qulaity activites, IQ/OQ/PQ, DOE, PPAP activities. Hands on knowledge in CAPA, CMM inspection,