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Director of Process Engineering

Protingent Fremont, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Position Title: Director of Process Engineering

Position Description: Protingent has an exciting direct hire opportunity with our client in Fremont, California.

Job Requirements:
  • Manage the technical and laboratory staff in the development and qualification of reagent chemistry and assays.
  • Plan, manage and deliver critical development projects as a core team leader
  • Manage development transfer activities between R&D and operations
  • Establish and maintain relationships to key suppliers and manufacturers
  • Develop R&D infrastructure by assuring processes, tools, capital equipment, and lab facilities are effective and compliant
  • Establish and maintain FDA compliant processes and documentation, including manufacturing and design control
  • Manage the analytical test lab to support manufacturing and QC activities for lot screening, calibration, and release, as well as for raw and intermediate materials testing.
  • Lead process optimization efforts to increase efficiency of chemistry and lab testing processes to support scaled manufacturing.
  • Contribute ideas to the Intuity patent portfolio by submitting patent disclosures and reviewing patent disclosures

Job Qualifications:
  • Experience leading large complex projects utilizing several scientific and engineering disciplines
  • Experience in design manufacture
  • Excellent verbal and written communication skills and the ability to develop employees and effective cross functional relationships
  • Experience in working in regulated product and manufacturing environments
  • Experience designing and setting up automated lab processes (desired, but not required)
  • Experience with blood glucose testing (desired, but not required)
  • Minimum of a BS in a related chemistry science discipline (analytical, biochemical, synthetic etc.); MS or Ph.D degree preferred
  • 10+ years experience in all phases of product development to launch for high volume medical devices
  • 7+ years in management and supervision of engineering teams or engineering departments 
  • Some travel required < 10%
  • Supervision: Supervision of laboratory personnel supporting manufacturing of reagent chemistries and production lots
  • Supervised by: Head of Manufacturing and Product Development

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Protingent

Address

Fremont, CA
USA