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:
Job Qualifications:
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.
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
USA
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