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.
This Project Engineer opportunity is in our Single Use Disposable Division located in our Rochester, NH facility. The Project Engineer works collaboratively in cross functional project teams and is primarily responsible for executing technical activities for customer projects involving complex disposable medical products.
- Lead and/or assist in the development of documentation required under Design Control requirements including: product drawings and specification; control plans; master validation plans, validation protocols and reports; risk assessments, hazard analysis, DFMEA, PFMEA; test procedures; IQ/OQ/PQ documentation; and manufacturing assembly instructions.
- Conduct analysis of raw data and develop statistical analysis with appropriate conclusions.
- Conceive, design and generate documentation for tooling and fixtures.
- Work directly with customers on product design specifications.
Skills & Experience Required:
- Bachelor of Science degree in an engineering discipline preferred
- 5+ years of relevant project engineering experience in the medical device industry introducing new products into manufacturing
- Familiarity and prior working experience under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR)
- Certificate in GD&T preferred
- Basic understanding of statistics and the ability to conduct statistical analysis with statistical software, Minitab preferred
- Experience using Microsoft Office, including Word, Excel, PowerPoint and Outlook