NextPhase Medical Devices
Job Summary:
Develop processes for new products to be transferred into production. Apply Lean principles to drive process efficiency improvements and cost reductions. Support Production daily so that all operations function in a safe and efficient mode. Perform maintenance and repairs to process equipment as needed.
Duties/Responsibilities: Develop detailed instructions under process development that can be translated into working assembly procedures. Working from drawings, specifications, and assembly procedures, effectively train production operators. Design, create, test and document measurement and assembly fixtures. Analyze and plan workflow, equipment placement and space requirements for new production layouts and also improve existing manufacturing efficiencies. Ensure that manufacturing equipment is operating in a safe and effective manner. Define and perform preventive maintenance and repair as needed. Ensure that output of the manufacturing processes is at a level according to defined standards. Monitor production scrap and analyze rejects. Manage and resolve production issues as they arise day to day. Identify and resolve repetitive and major production issues that are adversely affecting department performance. Lead and compose a cross-functional Process Failure Mode and Effect Analysis (pFMEA). Support new product introductions as assigned by partnering with New Product Development engineers and participate in project team meetings. Possess statistical competencies to conduct multi-factorial Design of Experiments, design and execute Process Validations, and present results demonstrating process capability. Assist New Product Development engineers in the design of basic fixtures for assembly, e.g. holding fixtures, cutters, go/no-go gauges. Working with an assigned Project Engineer to the product line, identify and implement continuous improvements regarding assembly techniques and equipment, improving First Pass Yields and reducing cycle time and/or scrap. Must maintain training to all current Next Phase Quality Documents, including the Quality Manual and all SOP's as assigned. Provide support in completing activities as assigned to resolve safety issues throughout the plant. Ability to work from home on occasion with advanced approval. Required Skills/Abilities:
Ability to read and interpret product and component 2D drawings, equipment schematics (electrical, pneumatic) and have a basic understanding of GD&T. Sound mechanical/electrical skills and an understanding of basic machinery principles. Poses a basic understanding of statistics and has the ability to conduct statistical analysis with statistical software, Minitab preferred. Microsoft Office Suite, including Word, Excel, PowerPoint, Visio. Education and Experience:
BS in Mechanical, Manufacturing, Industrial, Electrical Engineering or a related Engineering discipline. 5-7 years of production support and process development experience, preferably in the medical device field. Familiarity and prior experience working under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR). Physical Demands:
Ability to lift 40 pounds. Working on computer workstation for extended periods. Stand on a production line for extended periods.
Working Hours: Monday - Friday 8:00am - 5:00pm
Develop processes for new products to be transferred into production. Apply Lean principles to drive process efficiency improvements and cost reductions. Support Production daily so that all operations function in a safe and efficient mode. Perform maintenance and repairs to process equipment as needed.
Duties/Responsibilities: Develop detailed instructions under process development that can be translated into working assembly procedures. Working from drawings, specifications, and assembly procedures, effectively train production operators. Design, create, test and document measurement and assembly fixtures. Analyze and plan workflow, equipment placement and space requirements for new production layouts and also improve existing manufacturing efficiencies. Ensure that manufacturing equipment is operating in a safe and effective manner. Define and perform preventive maintenance and repair as needed. Ensure that output of the manufacturing processes is at a level according to defined standards. Monitor production scrap and analyze rejects. Manage and resolve production issues as they arise day to day. Identify and resolve repetitive and major production issues that are adversely affecting department performance. Lead and compose a cross-functional Process Failure Mode and Effect Analysis (pFMEA). Support new product introductions as assigned by partnering with New Product Development engineers and participate in project team meetings. Possess statistical competencies to conduct multi-factorial Design of Experiments, design and execute Process Validations, and present results demonstrating process capability. Assist New Product Development engineers in the design of basic fixtures for assembly, e.g. holding fixtures, cutters, go/no-go gauges. Working with an assigned Project Engineer to the product line, identify and implement continuous improvements regarding assembly techniques and equipment, improving First Pass Yields and reducing cycle time and/or scrap. Must maintain training to all current Next Phase Quality Documents, including the Quality Manual and all SOP's as assigned. Provide support in completing activities as assigned to resolve safety issues throughout the plant. Ability to work from home on occasion with advanced approval. Required Skills/Abilities:
Ability to read and interpret product and component 2D drawings, equipment schematics (electrical, pneumatic) and have a basic understanding of GD&T. Sound mechanical/electrical skills and an understanding of basic machinery principles. Poses a basic understanding of statistics and has the ability to conduct statistical analysis with statistical software, Minitab preferred. Microsoft Office Suite, including Word, Excel, PowerPoint, Visio. Education and Experience:
BS in Mechanical, Manufacturing, Industrial, Electrical Engineering or a related Engineering discipline. 5-7 years of production support and process development experience, preferably in the medical device field. Familiarity and prior experience working under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR). Physical Demands:
Ability to lift 40 pounds. Working on computer workstation for extended periods. Stand on a production line for extended periods.
Working Hours: Monday - Friday 8:00am - 5:00pm