Manufacturing Engineer II
Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations.
Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments.
The Freudenberg Group employs some 50,000 people in around 60 countries worldwide and generates sales of nearly 9 billion euros.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world.
We are a global provider for medical device design and manufacturing with 11 locations worldwide and more than 1,800 employees.
Innovation is at the core of our company and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies.
Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career.
Come join us and together we can make a difference in the future of healthcare.
You support our team as Manufacturing Engineer II Responsibilities Work collaboratively with engineers and customer personnel to design and develop silicone extrusion and molding processes using existing and innovative technologies.
Develop process validation protocols and reports, in accordance with applicable corporate procedures and in conjunction with senior engineers and the customer project team.
Specify new and existing product processes at a high level through the creation of process flowcharts and diagrams.
Create bills of materials, manufacturing procedures, and routers for components, assemblies, packaging, labeling, and other documents needed for the device master record.
Specify required machinery, fixtures, gauges, and other equipment needed for the verification and manufacture of medical devices.
Work with internal resources to obtain and plan for the installation of equipment in a clean environment.
Create and execute Installation Qualification protocols and reports.
Design or aid in the design/modification of extrusion and molding processing tooling.
Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch and subsequent sustaining engineering actions.
Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
Ensure developed processes meet or exceed the required cycle time to meet initial production forecast and cost.
Create DOEs to characterize and improve processes.
Initiate improvements in new and existing processes to improve part quality/yields, cycle times, and to reduce cost, using LEAN manufacturing and Six Sigma skills.
Investigate and/or create EO (Engineering Change Orders), disposition material, develop and implement process changes and proper documentation of any such changes.
Attend daily meetings to provide communication and technical support to meet daily production requirements and NPI project timelines.
Maintain adherence to company policies, safety/ergonomic standards, good housekeeping.
Qualifications Bachelor of Science in Mechanical, Manufacturing, Industrial Engineering.
EIT or PE a plus.
Minimum 3 years of experience as a process, validation, or manufacturing engineer in a manufacturing environment.
Medical manufacturing experience is preferred.
Experience in silicone, plastic, or rubber extrusion or molding manufacturing preferred.
Must possess a hands-on mechanical aptitude.
Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.
Ability to provide accurate inputs for the preparation of project timelines and estimates.
Proficient with use of Microsoft Office applications including Word, Excel, Visio and PowerPoint.
Proficient with use of SolidWorks 3D CAD software to create solid models and engineering drawings.
Able to learn and use MRP systems; SAP preferred.
Ability to utilize metrology equipment such as pin gauges, calipers, micrometers.
CMMs.
Ability to learn and use a variety of problem solving methods to find solutions to complex engineering problems, root cause analysis, fault-tree analysis, DMAIC, 8D, 5-whys.
Experience in a structured regulatory environment with advanced quality systems such as ISO13485, FDA CFR 21, ISO 9001, AS9100, TS16949, or equivalent preferred.
Certifications in LEAN manufacturing, SPC, or Six Sigma technique a plus.
Recommended Skills Aerospace Basic Quality System Standards Assembly And Installation Cad Curiosity Define Measure Analyze Improve And Control (Dmaic) Forecasting Estimated Salary: $20 to $28 per hour based on qualifications.
Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments.
The Freudenberg Group employs some 50,000 people in around 60 countries worldwide and generates sales of nearly 9 billion euros.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world.
We are a global provider for medical device design and manufacturing with 11 locations worldwide and more than 1,800 employees.
Innovation is at the core of our company and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies.
Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career.
Come join us and together we can make a difference in the future of healthcare.
You support our team as Manufacturing Engineer II Responsibilities Work collaboratively with engineers and customer personnel to design and develop silicone extrusion and molding processes using existing and innovative technologies.
Develop process validation protocols and reports, in accordance with applicable corporate procedures and in conjunction with senior engineers and the customer project team.
Specify new and existing product processes at a high level through the creation of process flowcharts and diagrams.
Create bills of materials, manufacturing procedures, and routers for components, assemblies, packaging, labeling, and other documents needed for the device master record.
Specify required machinery, fixtures, gauges, and other equipment needed for the verification and manufacture of medical devices.
Work with internal resources to obtain and plan for the installation of equipment in a clean environment.
Create and execute Installation Qualification protocols and reports.
Design or aid in the design/modification of extrusion and molding processing tooling.
Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch and subsequent sustaining engineering actions.
Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
Ensure developed processes meet or exceed the required cycle time to meet initial production forecast and cost.
Create DOEs to characterize and improve processes.
Initiate improvements in new and existing processes to improve part quality/yields, cycle times, and to reduce cost, using LEAN manufacturing and Six Sigma skills.
Investigate and/or create EO (Engineering Change Orders), disposition material, develop and implement process changes and proper documentation of any such changes.
Attend daily meetings to provide communication and technical support to meet daily production requirements and NPI project timelines.
Maintain adherence to company policies, safety/ergonomic standards, good housekeeping.
Qualifications Bachelor of Science in Mechanical, Manufacturing, Industrial Engineering.
EIT or PE a plus.
Minimum 3 years of experience as a process, validation, or manufacturing engineer in a manufacturing environment.
Medical manufacturing experience is preferred.
Experience in silicone, plastic, or rubber extrusion or molding manufacturing preferred.
Must possess a hands-on mechanical aptitude.
Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.
Ability to provide accurate inputs for the preparation of project timelines and estimates.
Proficient with use of Microsoft Office applications including Word, Excel, Visio and PowerPoint.
Proficient with use of SolidWorks 3D CAD software to create solid models and engineering drawings.
Able to learn and use MRP systems; SAP preferred.
Ability to utilize metrology equipment such as pin gauges, calipers, micrometers.
CMMs.
Ability to learn and use a variety of problem solving methods to find solutions to complex engineering problems, root cause analysis, fault-tree analysis, DMAIC, 8D, 5-whys.
Experience in a structured regulatory environment with advanced quality systems such as ISO13485, FDA CFR 21, ISO 9001, AS9100, TS16949, or equivalent preferred.
Certifications in LEAN manufacturing, SPC, or Six Sigma technique a plus.
Recommended Skills Aerospace Basic Quality System Standards Assembly And Installation Cad Curiosity Define Measure Analyze Improve And Control (Dmaic) Forecasting Estimated Salary: $20 to $28 per hour based on qualifications.
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