Job Description
The Manufacturing Engineer will provide engineering support for the operational issues pertaining to the production of a full line of surgical positioning products, in a Class 1 FDA regulated environment.
Essential Duties And Responsibilities:
Use mechanical engineering skills to develop solutions for assembly and design problems and to support New Product Development, Purchasing and external vendors. \Develop and maintain effective and economical manufacturing processes. Responsible for work instructions, regulatory compliance, processing engineering changes, troubleshooting problems, and supporting changes in production methods.
Responsible for total product quality, which includes resolving quality problems, certifying processes, and implementing process control.
Initiate, Prepare and Complete Engineering Change Orders.
Conduct and document engineering investigations and tests.
Revise and prepare Engineering Documentation - Drawings, 3D Models, Test Protocols, BOM's, etc.
Participate in activities related to NCMR, inspection and complaint evaluation.
Participate in Cost Reduction Activities and product redesigns.
Participate in NPD teams and Cost teams to insure DFMA of products, review drawings, work instructions, BOM's and other engineering documents and successful transfer products to manufacturing through validation testing.
Qualifications:
2+ years of experience working in a medical product environment is preferred.
Degree in Mechanical or Manufacturing Engineering.
Innate mechanical engineering skills and hands on mechanical aptitude.
Computer experience in Windows, Microsoft Office; Excel, Word, PowerPoint and Outlook.
Strong organizational, communication and written skills.
Self-motivated/Self-driven, enthusiastic, cooperative, and positive behavior.
Proficient with SolidWorks or another CAD software program.
Qualifications
Additional Information