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Form of workJob Description
Job Title: Manufacturing Engineer- Medical Device
Job Location : North Haven, CT
Job Description:
With an understanding of product designs and component interactions, specify part material selections and design features to effectively balance functionality with manufacturability and cost.
Participate in Engineering meetings and Quality Design FMEA meetings.
Complete and document Design for Manufacturability (DFM) analyses and drive effective resolutions pertaining to any identified risks.
Participated in the Capital Expense Request (CER) process, specifying costs for Component Tooling and any related Test or Inspection Fixtures, with consideration to product standard cost targets and capacity demands.
Contributor to project business studies, providing Engineering Estimates of production component parts and subassemblies based on knowledge of materials and processing costs.
Key team member in the supplier selection process, including the definition of tooling and manufacturing process strategies.
Work collaboratively with the Quality, Sourcing, and cross-functional teams to review, disposition, and approve PPAP submissions.
Facilitate Early Supplier Involvement (ESI) technical meetings, effectively document agreements and risks, and drive closure of open action items.
Generate electronic Purchase Requisitions based on quotations from selected suppliers for the build of Capital Tooling and qualification of Production Processes.
Participate and critique mold tool designs. Be accountable for the quality of the tooling design.
Strategic supplier contact during tool fabrication and part qualification, providing technical support and project management resources.
Responsible for review and approval of supplier tool designs prior to initiation of fabrication.
Execute Materials Engineering product transfer deliverables from the Pilot to the receiving Plant.
Advise Management of any unmitigated risks and/or developments that could affect TTM or standard cost.
REQUIREMENTS:
Required:
BS Mechanical or Manufacturing Engineering, or Equivalent
Preferred:
MS Mechanical or Manufacturing Engineering
Min 7 yrs. applicable experience
Demonstrated knowledge of DFMEA and PFMEA.
Demonstrated knowledge of GD&T.
Demonstrated knowledge of DFM & DFA principles.
Expertise in the use of mold-filling simulations, such as Moldflow, Sigma soft, or Moldex3d.
Significant plastic manufacturing process experience, including Injection Molding, Insert Molding, and Multi-Shot Molding.
Significant experience with medium to high-volume component parts and subassembly manufacturing best practices.
Strong familiarity with statistical analyses, including process capability, process control, Design of Experiments, etc
Strong understanding of Process Validation and Production Part Approval Process (PPAP) for component part qualification.
Strong Project Management skills.
Job Location : North Haven, CT
Job Description:
With an understanding of product designs and component interactions, specify part material selections and design features to effectively balance functionality with manufacturability and cost.
Participate in Engineering meetings and Quality Design FMEA meetings.
Complete and document Design for Manufacturability (DFM) analyses and drive effective resolutions pertaining to any identified risks.
Participated in the Capital Expense Request (CER) process, specifying costs for Component Tooling and any related Test or Inspection Fixtures, with consideration to product standard cost targets and capacity demands.
Contributor to project business studies, providing Engineering Estimates of production component parts and subassemblies based on knowledge of materials and processing costs.
Key team member in the supplier selection process, including the definition of tooling and manufacturing process strategies.
Work collaboratively with the Quality, Sourcing, and cross-functional teams to review, disposition, and approve PPAP submissions.
Facilitate Early Supplier Involvement (ESI) technical meetings, effectively document agreements and risks, and drive closure of open action items.
Generate electronic Purchase Requisitions based on quotations from selected suppliers for the build of Capital Tooling and qualification of Production Processes.
Participate and critique mold tool designs. Be accountable for the quality of the tooling design.
Strategic supplier contact during tool fabrication and part qualification, providing technical support and project management resources.
Responsible for review and approval of supplier tool designs prior to initiation of fabrication.
Execute Materials Engineering product transfer deliverables from the Pilot to the receiving Plant.
Advise Management of any unmitigated risks and/or developments that could affect TTM or standard cost.
REQUIREMENTS:
Required:
BS Mechanical or Manufacturing Engineering, or Equivalent
Preferred:
MS Mechanical or Manufacturing Engineering
Min 7 yrs. applicable experience
Demonstrated knowledge of DFMEA and PFMEA.
Demonstrated knowledge of GD&T.
Demonstrated knowledge of DFM & DFA principles.
Expertise in the use of mold-filling simulations, such as Moldflow, Sigma soft, or Moldex3d.
Significant plastic manufacturing process experience, including Injection Molding, Insert Molding, and Multi-Shot Molding.
Significant experience with medium to high-volume component parts and subassembly manufacturing best practices.
Strong familiarity with statistical analyses, including process capability, process control, Design of Experiments, etc
Strong understanding of Process Validation and Production Part Approval Process (PPAP) for component part qualification.
Strong Project Management skills.
