Posted in Architecture 9 days ago.
This job brought to you by eQuest
Location: Jacksonville, Florida
Assists the development engineering staff with various support projects of a technical nature.
• Assist Product Engineers with the following:
o Design new products
o Evaluate and implement product design changes for multiple product lines
o Identify design requirements by working closely with marketing professionals and customers, as well as potentially attending surgeries
o Create prototypes to assist in gathering voice of the customer feedback for potential projects
o Investigate and analyze problems using Six Sigma and Lean methodologies
o Execute product test protocols, including analysis of test results through statistical methods
o Execute experiments, including mechanical testing, to minimize technical risks associated with device design
o Collect and analyze data
o Create and implement engineering drawings and other product documentation
o Identify and mitigate project or design risks throughout the project plan
o Provide technical engineering support for international regulatory submissions, post market surveillance activities, process improvements, and supplier changes
• Create 3D models and 2D prints for new products utilizing Solid Edge
• Complete assigned project and daily tasks with a sense of urgency
• Complete repetitive design activities for Pectus Product line
• Strong communication skills and ability to work well within a team environment
• Maintain design control documentation for FDA and ISO 13485
• Possible OT required during certain time periods to support heavy volume of surgeries
• Bio-materials, biomedical industry a plus;
• Design control experience, FDA, cGMP, a plus;
• Computer skill necessary (Excel, Word, Solidedge, etc.)
• Familiar with basic life science & engineering terminology. Able to read blueprints.
• Working knowledge of the systems and procedures of Research, Development, Manufacturing, Sourcing, Distribution, Logistics and Quality Assurance a plus.
• Demonstrated good planning skills to effectively organize, prioritize, and balance workload.
• Demonstrated ability to make suggestions for improvements to general processes related to Product Development practices.
• Associate degree diploma or equivalent with experience in a research, development, manufacturing environment.
• Minimal – most local