Senior Mechanical Design Engineer

Responsibilities:

• Interact with Design Engineers to influence new product designs, design for mold-ability. Plastic and Metal part design review to make sure it meets recommended design practices.
• Review drawing tolerances to insure that they meet SPI standards where applicable.
• Plastics and Metal Injection molded tool design review with molder and toolmaker to ensure tool design is capable of producing high quality parts.
• PPAP requirements. Write injection molding validation protocols using scientific injection molding principles. Collaborate with engineering, and quality engineering. Follow up on protocols approvals.
• Review and summarize molding validation data from suppliers, write validation reports and follow up with the appropriate personnel on approvals.
• Review injection molding design of experiments, viscosity study, gate freeze study, CPK, and inspection data, discuss out of spec dimensions with the engineers, tool makers, and molder so that corrective action can be implemented.
• Ability to manage multiple projects, and to develop and maintain tool qualification schedules.
• Work with molding suppliers to maintain healthy tool life, the tooling life cycle, to maintain an accurate tooling inventory spreadsheet (MML) in order to proactively plan for tool maintenance and replacement.
• Supplier visits for tool validations, tool repair/maintenance requirements, et.
• Update of the Master Mold List (tooling inventory)
• Work with Suppliers, establish and validate secondary operations processes to provide capable processes.

Additional responsibilities:

• Demonstrates advanced knowledge of Lean and Six Sigma processes and techniques in accordance with GMP's
• Independently analyzes moderately-complex technical process problems and make recommendations for resolution is a plus
• Independently performs moderately-complex process capability studies and process optimization is a plus
• Assist in supplier audits and selection
• Plastics and Metal material selection experience is a plus.
• Perform material strength analysis with FEA results, and recommend alternate design solutions is a plus.
• Perform mold flow and warp analysis to include part fill, sink, weld lines analysis, and optimization of gate location is a plus.
• Review assembly design for ease of manufacturability (DFMA) is a plus.
• Experience in tool design and qualification of die cast components is a plus.

Requirements:

• Bachelor’s Degree in Mechanical Engineering or Engineering or related field, or relevant equivalent experience.
• Minimum 5 years in mold design / procurement and plastics and metal processing experience.
• Tooling experience with plastic and metal injection molding is required.
• Experience with plastic and metal materials, processing and scientific molding practices.
• Proficiency in Solidworks and understanding of Flow Analysis tools.
• Excellent technical skills including project management, organization, planning and capital budgets relating to mold procurement and verification.
• Demonstrated ability to apply problem solving and data analysis methods.
• Excellent PC skills with proficiency in MS Office (Word, Excel, PowerPoint), various CAD programs.
• Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.
• Experience in an FDA regulated quality environment
• Willingness and ability to travel domestically and internationally up to 25%.