Manufacturing Engineer

Company: HCL Technologies
Location: Warsaw
Posted on: June 23, 2022

Job Description:

• Develop and execute all the Process Validation deliverables / activities which include IQ, OQ, PQ, SOP, Validation Plan, Functional Requirement Specifications (FRS), User Requirement Specifications (URS), Requirement Traceability Matrix (RTM) and summary reports.
• Perform capability analysis (Cpk, Ppk) on test data, investigate outliers and work on sampling plans (Minitab).
• Perform Design Of Experiments (DOE) to determine sampling plans.
• Develop Test Method Validations (TMV's) using the principle of Gauge R&R, testing methodologies
• Collaborate with cross functional teams for various projects following Quality Management systems in compliance with ISO 13485, 21 CFR 820,
• Utilize fundamental Engineering to apply Lean, Kaizen and Six Sigma in the improvement process.
• Prepare detailed project plans with breakdown of all activities, milestones, efforts, and timeline in concurrence with project members & stakeholders
• Monitor and evaluate project resource needs ensuring the continuity of project and timely communication to stakeholders
• Track project milestones, organize weekly governance meetings, and provide regular status reports

Keywords: HCL Technologies, South Bend , Manufacturing Engineer, Engineering , Warsaw, Indiana