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New Product Introduction Engineer

Location: San Jose, CA, United States
Job # 10543720
Date Posted: 03-06-2018
New Product Introduction Engineer
San Jose, CA 95131
Salary Rate: $90,000/yr
Direct Hire Role
About Company and Opportunity:
Our client is a leading global supplier of solutions for the biopharma, forensic and diagnostic industries. The company is a leader in the development, production and distribution of advanced automation and detection solutions for the world‘s leading life science laboratories. Ambitious to contribute to the quality of life of humankind by enabling our customers to make the world and our community a healthier and safer place.

This is a permanent opportunity to grow with a fast paced biotech company including benefits, PTO, and retirement plans. You will be a major contributor to our organization and essential to the growing need in our Manufacturing department.
Essential Job Duties:
Reporting to the Manufacturing Engineering Manager, we are seeking the right individual to work closely with the R&D and Marketing Departments on developing new products and performing NPI tasks that will be instrumental in the effective and successful transfer of new products from the design process to the manufacturing process.
  • Responsible for establishing all manufacturing aspects of new products from design concept to full production release.
  • Review and provide input to the design team members to ensure that the product design is correctly translated into production specification.
  • Design and develop assembly procedures, tooling, fixtures, process FMEAs and documentation in compliance with internal quality system and ISO requirements.
  • Develop Manufacturing test procedures and equipment.
  • Develop validation protocols for new processes, equipment, and software.
  • Prepare proposals for any personnel requirements once product has been transferred to production. 
  • Establish and document standard manufacturing times.
  • Evaluate current production process capabilities, including personnel, and generate action plans to meet identified needs.
  • Ensure that proper protocols for Equipment Installation Qualification and Operations Qualification are completed for new equipment prior to introduction into manufacturing.
  • Review designs and provide input to ensure design for manufacturability (DFM).
  • Create, evaluate and verify manufacturing specifications and requirements.
  • Collaborate with all functional groups regarding new product development, marketing, and customer support.
  • Provide technical support and guidance to manufacturing personnel.
Essential Requirements / Training:
  • Bachelor’s Degree in Mechanical, Electrical, Manufacturing or Chemical Engineering with 2-5 years of experience with new product introduction and sustaining manufacturing in an ISO and FDA regulated atmosphere is required.
  • Experience designing tooling and fixtures is required.
  • Must possess excellent hands-on mechanical aptitude.
  • Excellent written and verbal communication skills, consensus building, professionalism and customer service skills are a must.
  • Must be able to work with limited supervision and in a team environment.
  • Applied Lean Techniques (5s, 7 waste, Six-Sigma, pareto charts, Cpk) is highly desirable.
  • Chemistry experience and design for manufacturability experience desirable. 
  • Experience manufacturing products involving servo and stepper motors, mechanisms and liquid handling preferred.
  • ProE, Solidworks, and programming experience is desirable.
If qualified, please apply with your resume in PDF or Word format. #DI
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