Our client is actively searching for a Design Engineer to design and develop new products for in-house production in main facility and other manufacturing sites within the corporate group.

• Upgrade older existing products, identifying areas to streamline or improve processes and quality
• Provide continuing product support for manufacturing, sales and quality on design requirements, customer needs, testing, CAPA and product documentation
• Coordinate with manufacturing at suitable stages during initial design to evaluate the designs ability to optimized for manufacturing in an efficient and economical manner
• Insure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Processes regarding process, design and development of new and existing product
• Perform DOE, correlation studies and apply statistical analysis for product improvements
• Apply FMEA process to implement sound engineering solutions
• Prove product design by developing test plans, adjusting design, running performance calculations, maintaining quality standards and approve prototypes
• Develop product literature by recording, interpreting and explaining technical data and product performance
• Responsible for product project management from prototype to full production based upon accurate project schedules and budgets

Position Qualifications and Requirements:

• Minimum of Bachelors Degree in Mechanical Engineering or other relevant Engineering discipline
• Prior injection molding experience preferred
  
• 2 years of related design and development experience in the medical device and/or component industry (college internship experience may be considered)
• Design Control experience including design and process verification and validation
• Understanding and experience in product design and development including the use of tools such as QFD, FEA, Risk Analysis, DFMA, SUS and GD&T
• Design Control experience including design and process verification and validation
• Strong design skills using Solidworks applications
• Understanding and application of ISO Quality System requirements and FDA regulations
• Excellent project management skills. Microsoft Project experience required.
• Knowledge, experience with application of Six Sigma statistical analysis and controls
• Superior verbal and written communication skills

Please send your resume to sgalloway@hotrun.net

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