Director of Process Engineering, Reagents and Chemistry

Position Summary:

Direct the scientific and technical staff in the development and manufacturing of a home based photometric blood glucose meter.  Provide senior level guidance and leadership to the technical team to assure on-time and compliant development programs that meet product requirements.

Director of Process Engineering, Reagents and Chemistry

Position Summary:

Direct the scientific and technical staff in the development and manufacturing of a home based photometric blood glucose meter.  Provide senior level guidance and leadership to the technical team to assure on-time and compliant development programs that meet product requirements.

Position Description and Responsibilities:

  • 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

Position 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 Education:

  • Minimum of a BS in a related chemistry science discipline (analytical, biochemical, synthetic etc.); MS or Ph.D degree preferred

Minimum Experience:

  • 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

Working Conditions:

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