NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single- use disposable medical devices. Headquartered in Waldwick, NJ, we also have manufacturing facilities in Rochester, NH and Tijuana, Mexico.
The Manufacturing Engineer position is based in our Rochester, NH facility and reports directly to the Director of Manufacturing. The Manufacturing Engineer is responsible for identifying and implementing continuous improvement ideas in support of safety, quality, delivery, and manufacturing using LEAN and Six Sigma techniques. The Manufacturing Engineers also partner with the New Product Development Engineering team in support of new product program transfers into stable manufacturing production.
Other responsibilities include:
- Provide engineering guidance and technical support to manufacturing cells and value streams.
- Design, create, test and document all assigned measurement and assembly fixtures.
- Document manufacturing processes, equipment, and fixtures that comply with regulations, policies, and procedures.
- Monitor and reduce scrap and analyze rejects.
- Perform and/or oversee preventive maintenance. Troubleshoot equipment and processes, recommending and performing corrective actions.
- Perform process qualification/validations.
- Identify and resolve production issues that impact operational performance.
- Research, purchase and install capital equipment to increase productivity.
- Manage and support production issues as they arise during day to day operations.
Required Skills, Knowledge and Experience:
- Familiarity and prior experience working under ISO 13485, ISO 14971: 2007 and 21CFR Section 820 (FDA QSR).
- Proficient in Microsoft Office Suite (Word, Excel, Project), Visio and CAD software (SolidWorks and AutoCAD preferred).
- Bachelor of Science degree in an engineering discipline preferred.
- 2+ year’ experience in a manufacturing environment within a regulated industry, i.e., medical devices, aerospace, automotive, or similar industry.
Unsolicited, Non-Contracted Agencies not subject to “finder’s fee”.
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