Ref No.: 18-08612
Location: South San Francisco, California
The successful candidate will support new product design, development and implementation of delivery devices and Client injection tools/aids for biologic therapeutics. Primary technologies include auto-injectors, basal infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges.
Major responsibilities will include the execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various designs. This will include the execution of routine and on-going R&D stability testing, design verification testing, complaint investigations and special testing requests.
He/she will work with design engineers to identify, develop, implement, qualify and validate new testing methods (and equipment if required) to meet capability and capacity needs of theproject, troubleshoot equipment failures, and ensure sample traceability and data integrity. The person will provide input and execute plans to maintain and improve laboratory safety. The successful candidate will be able to support the design engineer in data analysis and interpretation, to identify questionable results and identify root cause.

2-3 years experience in the Pharmaceutical, Biotech or Medical Device industry is preferred.
Direct experience in executing physical test methods, equipment procurement, and qualification of equipment.
Familiarity with statistical tools such as JMP or Minitab, and execution of Gage R&R or similar measurement systems analyses.
Experience with statistical handling and interpretation of data, technical report writing and reviewing.
Expertise in electrical/mechanical instrumentation, data acquisition, and equipment maintenance.
Prior experience working in a matrix organization with a highly cross-functional and collaborative environment