Project Engineer

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.

Position Summary:

The Project Engineer position is based in our Rochester, NH facility and reports directly to the Vice President, Engineering. The Project Engineer is responsible for managing all technical activities for internal and external customer projects involving complex disposable medical products. The Project Engineer works as part of a Value Stream Team and interacts regularly with customers to resolve design and process challenges as well as scope changes.

Other responsibilities include:

  • Managing project tasks to ensure customer deliverables are on time and on budget.
  • Provide direction to supporting technical staff and production assemblers.
  • Lead and/or assist in the development of documentation required under Design Control requirements.
  • Conduct analysis of raw data and develop statistical analysis with appropriate conclusions.
  • Conceive, design, and generate documentation for tooling and fixtures.
  • Develop Calibration and Preventative Maintenance programs for equipment supporting projects.

Required Skills, Knowledge and Experience:

  • 10+ years prior Information Technology experience required preferably in a manufacturing environment.
  • Familiarity and prior experience working under ISO 13485:2016, ISO 14971: 2007 and 21CFR Section 820 (FDA QSR).
  • Previous work experience in a contract manufacturing environment preferred.
  • Use of statistical software, Minitab preferred.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project), Visio and CAD software (SolidWorks preferred).
  • Proficiency in manufacturing processes including but not limited to injection molding, extrusion, metal forming and machining, bonding techniques (adhesives), ultrasonic welding, light assembly and medical grade (sterile) packaging.
  • Bachelor of Science degree in an engineering discipline preferred.
  • Certificate in Geometric Dimensioning & Tolerancing (GD&T) preferred.
  • 5-7 years in the medical device industry with a proven track record of successfully developing new products and processes, including demonstrated success introducing new products into manufacturing.

Unsolicited, Non-Contracted Agencies not subject to “finder’s fee”.