Manufacturing Engineer

San Jose, CA

Posted: 08/19/2019 Employment Type: Contract Industry: Medical Device Job Number: j-298

The Sr. Manufacturing Engineer – Disposable/Consumable Products will act as an individual contributor within the Manufacturing Engineering team to develop and improve upon the disposables/consumable products utilized within the Tablo System.  This person will interact with both internal resources, as well as external suppliers and Contract Manufactures (CM’s) on efforts to improve product quality, increase manufacturing capacity; bring down costs.   The Manufacturing Engineer will proactively interact with internal and external customers, vendors, and contractors including PM, the Director of Advanced Engineering and Manufacturing, and cross functional members of the Organization. 

  • Contribute in a hands-on technical role with product development: including modifying existing designs or coming up with new design proposals, conducting prototype evaluations, releasing Engineering Change Orders (ECO’s), qualification planning and protocol writing, testing.; all within a regulated Medical Device Quality Management System 
  • Engage with external suppliers to ensure project objectives are met and that product performance meets customer and quality requirements 
  • Work with PMO team to stick with project schedules, and finding creative ways to shorten timelines. 
  • Actively and independently work with cross-functional teams 
  • Maintain an understanding of the product design 

Requirements/Qualifications 

Required: 

  • MS. in Mechanical Engineering or equivalent experience 
  • Minimum of 7 years of experience in the manufacturing/ design of medical products, with a strong background in the manufacturing & development of disposable/single use medical devices 
  • Strong knowledge of FDA regulations, GMP, and ISO requirements 
  • Strong track record in design, testing, and manufacturing considerations 
  • Demonstrated ability to find creative ways to meet tight timelines 
  • Strong communication skills 

Preferred: 

  • MS. or PhD in Mechanical Engineering (or similar) 
  • Experience with extrusion, ultrasonic welding, tubesets, and molded plastics technologies 
  • Experience with high volume manufacturing assembly processes 
  • Design for manufacturability and cost optimization experience 
  • SolidWorks experience 

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.