Engineer/Process Control - Medical Device

POSITION SUMMARY:  

The Engineer is primarily responsible for research and development, design, validation, process improvement and documentation of new and existing products.

Local candidates only.

ESSENTIAL FUNCTIONS:

• Researches materials, assembly techniques and processes and implements manufacturing process improvements.
• Generates new designs and drawings via SolidWorks.
• Maintains a working knowledge of new technologies which may improve operations, and develops recommendations accordingly.
• Confers with vendors to source and specify materials, processes, tooling or supplies for product manufacturing
• Develop and execute testing and design validation protocols for new products/processes/equipment at various stages of development.
• Coordinate product transfer and production ramp up with operations to include validation and related documentation and training.
• Generates and reviews ECO’s for changes to current processes and products.

MINIMUM QUALIFICATIONS:

• BSME or Biomedical Engineering or equivalent four-year engineering degree with 2 or more years of experience in a GMP manufacturing environment.
• Excellent written and verbal communication skills.
• Must be proficient w/ Solid Works and CAD software.
• Must be proficient with MS Excel, Word, PowerPoint and Project.
• Demonstrated problem solving ability in a cross-functional team environment.
• Familiar with current ISO and FDA regulations.
• Diverse background preferred in fabrication techniques including, but not limited to, injection molding, thermo-forming, machining, and die cutting.