Support the daily operation of manufacturing to ensure that production processes operate in a safe and efficient mode while providing maintenance and repairs to process equipment as needed. Utilize lean manufacturing principles to drive projects resulting in efficiencies and cost savings to the manufacturing process.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.- Create validations consisting of IQ, OQ, PQ, MVP, and Control Plans.- 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.- Assist Project 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.- Identify and resolve repetitive and major production issues that are adversely affecting department performance.- Manage and resolve production issues as they arise day to day.- Support new product introductions as assigned by partnering with New Product Development engineers and participate in project team meetings.- 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 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.- Microsoft Office, including Word, Excel, PowerPoint, Visio.- A basic understanding of statistics and the ability to conduct statistical analysis with statistical software, Minitab preferred.- Familiarity and prior experience working under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR).- Good written and verbal communication skills.- Experience with CAD/CAE software, preferably SolidWorks.BS in Mechanical Engineering or a related Engineering discipline- 3-5 years of production support and process development experience, preferably in the medical device field.- Lean and/or Six Sigma training preferred.**Salary**: $1.00 - $2.00 per monthWork Remotely:- No