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Manufacturing Engineer

In New Jersey / United States

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Manufacturing Engineer   

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JOB TITLE:
Manufacturing Engineer
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Iselin New Jersey / United States

JOB DESCRIPTION :
  • Developed Manufacturing procedures, Engineering documentation and performs validation activities.
  • Maintained and updated process control documentation in Engineer Change Order (ECO's), Engineer Change Request (ECR's) Creative, Review and Approval Specifications, Process FMEA's, Control plans.
  • Responsible for key decisions making in equipment Design review meetings
  • Updating Work Instructions, SOP's, Bill of Materials (BOM), Process Flow Diagram
  • Develops and leads process validation activities. 10%
  • Developed Master Validation Plan (MVP), Process Validation (PV) Quality Risk Management Plan (QRMP) and Failure Mode Effective analysis (FMEA)
  • Ensured that equipment qualifications are performed according to SOP's and compliant with cGMP requirements
  • Executed Inline and Offline Test Method Validation activities and validation Activities (IQ, OQ&PQ) for newly installed equipment's.
  • Generates, justifies, and changes manufacturing documentation. 10%
  • Modified Manufacturing Procedures, Working Instructions for current production processes and Inspection
  • Performed the GAP analysis in MP's and qualification reports
  • Worked with Production, Quality/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes
  • Developed best practice to improve production capacity, quality and reliability
  • Leads purchase of new capital equipment and upgrades of existing capital equipment. Perform or manage the installation, operational, or process qualifications. 10%
  • Manage equipment installation and executing SAT protocols
  • Performed environmental health and safety (EHS) assessment for the new equipment installed
  • Provided continuous support for continuous improvement to manufacturing operational and implementing new technologies including development of the process and evaluating quality of the process, cost, capacity, and capabilities alternative
  • Interface with customer on a regular basis to resolve issue
  • Manages projects to design, build, and qualify new products. 10%
  • Planning and documenting test information to validate product performance following a design change or improvement
  • Worked with the design and development teams as assigned on new products, implementing design for manufacturability
  • Performed Design Verification and Design validation for the Design Input and Output
  • Created and updated Mechanical design failure effective mode analysis (MDFMEA) Electrical design failure mode analysis EDFMEA
  • Provides direction and supervision to extrusion technician(s). 10%
  • Acts independently with minimal supervision to execute engineering projects specifically targeting to solve engineering problems related to process
  • Completes design and development projects by training and guiding technicians
  • Provided technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective actions
  • Supported sustainable, continuous improvement to the device and combination product Quality Management System (QMS) and best practices for device lifecycle processes by identifying areas for improvement and engaging in remediation
  • Participates in cross-functional teams comprised of representatives from R&D, Production, Regulatory Affairs, Quality and other departments. 10%
  • Reviewed or coordinated vendor activities to support product development
  • Worked as cross functional lead in providing Quality assistance to ongoing project
  • Supported Quality in Manufacturing areas for system that are related to inspection and validation of protocol
  • Supported regulatory affairs for performing regulatory impact assessment for US and OUS
  • Investigate & facilitate resolution of production & technical issues including root cause identification, corrective actions, and error proofing. 10%
  • Used Fish bone Diagram, 8D technique, 5whys and 6M to identify the issue
  • Identified the risk and performed root cause on mitigation plan
  • Coordinated corrective actions, maintain report files for Nonconformance (NC) and CAPA's related to new product development and recently transferred processes
  • Utilize various tools (DMAIC, Gage R&R, Cp, Cap, SPC, etc.) to analyze & improve processes, components, & products. 10%
  • Performed Test Method Validations for the equipment, Design of Equipment (DOE) and accepting sampling and also conducting Gage R&R
  • Performed process capability study in statistical tool (Minitab) and attain Cpk, Ppk values
  • Developed process control charts for identifying USL (upper Limit) and LSL (Lower Limit)
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 5%
  • Developed and performed 21 CFR PART 820 Process Flows, Control plans, Measurements Systems Analysis and Process Capability Analysis
  • Conducted and scheduled internal audits to ensure compliance according to cGMP, FDA, ISO 13485 and 21 CFR 820 guidelines and internal quality system
  • Ensure that all designs requirement for labels are met as per the FDA regulations
  • Perform other related duties and responsibilities, as assigned. 5%
  • Continuous improvement and elimination of waste through ongoing analysis and identification of inefficiencies within the system
  • Performed the scrap analysis as part of cost saving project
  • Reduced the Lead time for the process out put
Education Requirement: Industrial engineering and closely related field

Position Details

Apr 12, 2021
S16174660656642832
New Jersey / United States
Iselin
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Manufacturing Engineer    Apply

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  • Developed Manufacturing procedures, Engineering documentation and performs validation activities.
  • Maintained and updated process control documentation in Engineer Change Order (ECO's), Engineer Change Request (ECR's) Creative, Review and Approval Specifications, Process FMEA's, Control plans.
  • Responsible for key decisions making in equipment Design review meetings
  • Updating Work Instructions, SOP's, Bill of Materials (BOM), Process Flow Diagram
  • Develops and leads process validation activities. 10%
  • Developed Master Validation Plan (MVP), Process Validation (PV) Quality Risk Management Plan (QRMP) and Failure Mode Effective analysis (FMEA)
  • Ensured that equipment qualifications are performed according to SOP's and compliant with cGMP requirements
  • Executed Inline and Offline Test Method Validation activities and validation Activities (IQ, OQ&PQ) for newly installed equipment's.
  • Generates, justifies, and changes manufacturing documentation. 10%
  • Modified Manufacturing Procedures, Working Instructions for current production processes and Inspection
  • Performed the GAP analysis in MP's and qualification reports
  • Worked with Production, Quality/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes
  • Developed best practice to improve production capacity, quality and reliability
  • Leads purchase of new capital equipment and upgrades of existing capital equipment. Perform or manage the installation, operational, or process qualifications. 10%
  • Manage equipment installation and executing SAT protocols
  • Performed environmental health and safety (EHS) assessment for the new equipment installed
  • Provided continuous support for continuous improvement to manufacturing operational and implementing new technologies including development of the process and evaluating quality of the process, cost, capacity, and capabilities alternative
  • Interface with customer on a regular basis to resolve issue
  • Manages projects to design, build, and qualify new products. 10%
  • Planning and documenting test information to validate product performance following a design change or improvement
  • Worked with the design and development teams as assigned on new products, implementing design for manufacturability
  • Performed Design Verification and Design validation for the Design Input and Output
  • Created and updated Mechanical design failure effective mode analysis (MDFMEA) Electrical design failure mode analysis EDFMEA
  • Provides direction and supervision to extrusion technician(s). 10%
  • Acts independently with minimal supervision to execute engineering projects specifically targeting to solve engineering problems related to process
  • Completes design and development projects by training and guiding technicians
  • Provided technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective actions
  • Supported sustainable, continuous improvement to the device and combination product Quality Management System (QMS) and best practices for device lifecycle processes by identifying areas for improvement and engaging in remediation
  • Participates in cross-functional teams comprised of representatives from R&D, Production, Regulatory Affairs, Quality and other departments. 10%
  • Reviewed or coordinated vendor activities to support product development
  • Worked as cross functional lead in providing Quality assistance to ongoing project
  • Supported Quality in Manufacturing areas for system that are related to inspection and validation of protocol
  • Supported regulatory affairs for performing regulatory impact assessment for US and OUS
  • Investigate & facilitate resolution of production & technical issues including root cause identification, corrective actions, and error proofing. 10%
  • Used Fish bone Diagram, 8D technique, 5whys and 6M to identify the issue
  • Identified the risk and performed root cause on mitigation plan
  • Coordinated corrective actions, maintain report files for Nonconformance (NC) and CAPA's related to new product development and recently transferred processes
  • Utilize various tools (DMAIC, Gage R&R, Cp, Cap, SPC, etc.) to analyze & improve processes, components, & products. 10%
  • Performed Test Method Validations for the equipment, Design of Equipment (DOE) and accepting sampling and also conducting Gage R&R
  • Performed process capability study in statistical tool (Minitab) and attain Cpk, Ppk values
  • Developed process control charts for identifying USL (upper Limit) and LSL (Lower Limit)
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 5%
  • Developed and performed 21 CFR PART 820 Process Flows, Control plans, Measurements Systems Analysis and Process Capability Analysis
  • Conducted and scheduled internal audits to ensure compliance according to cGMP, FDA, ISO 13485 and 21 CFR 820 guidelines and internal quality system
  • Ensure that all designs requirement for labels are met as per the FDA regulations
  • Perform other related duties and responsibilities, as assigned. 5%
  • Continuous improvement and elimination of waste through ongoing analysis and identification of inefficiencies within the system
  • Performed the scrap analysis as part of cost saving project
  • Reduced the Lead time for the process out put
Education Requirement: Industrial engineering and closely related field