Product and Process Development Engineer, Sustaining
$31,200–$31,200 year
On-siteMorrisville, North Carolina, United States
Job Summary
Organize and manage multiple sustaining engineering projects for high-volume emergency medicine devices, ensuring timely completion and creative solutions for product modifications. Develop and maintain Design History File documentation, create SolidWorks 3D models, and coordinate design verification protocols for existing medical devices. Design, build, and validate test-fixturing and measurement equipment while researching alternative manufacturing methods to improve production costs. Gather data for marketing, engineering, and regulatory requests, update risk documentation, and lead integrated core teams with Engineering, Quality, and Regulatory partners. Collaborate with manufacturing plants in the US, Mexico, and Czech Republic, as well as third-party suppliers, to support sustaining efforts. Travel up to 10% internationally; requires a bachelor's degree in engineering and SolidWorks experience.
Required Qualifications
- Possession of bachelor's degree in engineering
- Experience in SolidWorks CADD (design/drafting) program
- Microsoft Office Suite, (Project, Word, and Excel)
- Principles and practices of professional engineering
- Speak and write English fluently
- The ability to travel to international locations is mandatory
Desired Qualifications
- Experience in molding, plastic extrusion and plastic part assembly processes and methods preferred
- Experience with U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices preferred
- Working to comply with ISO and ASTM testing methods preferred
- Knowledge of regulations pertaining to medical device design and design modifications preferred
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