NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, Waldwick, NJ and Tijuana, Mexico.
Based in our Rochester, NH facility, the Manufacturing Engineer will support the daily operation of single use disposable product manufacturing to ensure that production processes operate in a safe and efficient mode while providing maintenance and repairs to process equipment as needed. The Manufacturing Engineer will utilize Lean Manufacturing principles to drive projects resulting in efficiency and cost savings to the manufacturing processSingle Use Disposable Division.
- Create validations consisting of IQ, OQ, PQ, Master Validation Plan, and Control Plans.
- Develop detailed instructions under process development that can be translated into working assembly procedures.
- Design, create and test document measurement and assebly fixtures.
- Ensure manufacturing equipment is operating in a safely and effectively. Define and preform preventative maintenance and repair as required.
- Partnering with Project Engineers, identify and implement continuous improvements regarding assembly techniques and equipment, improving First Pass Yield, and reducing cycle times and scrap.
- Support new product introductions as assigned by partnering with New Product project teams.
Skills & Experience Required:
- Bachelor of Science degree in Mechanical Engineering or related Engineering discipline
- 5+ years of relevant production support and process development experience, preferrably in the medical device or similar regulated industry
- Ability to read and interpret product and component 2D drawings, equipment schematics and have a basic understanding of GD&T
- Lean and/or Six Sigma training preferred
- Experience using Microsoft Office, including Word, Excel, PowerPoint and Outlook
- Experience using CAD/CAE Software, preferably SoldWorks