Gilead Sciences, Inc.
**Device Engineer III** to lead testing activities as a subject matter expert for cross-functional project teams developing Medical Devices and Combination Products (e.g., autoinjectors, pre-filled syringes, needle safety devices, co-packaged device kits). Qualified candidates will focus on 1) lab operations management, test method development and characterization testing in Gilead’s device and packaging lab; 2) management of test method development/validation and design verification at external testing labs; and 3) execution method transfers for release testing.
We are seeking a highly motivated and detail-orientated **Specific Responsibilities** **Knowledge & Skills** Strong verbal, written, and interpersonal communication skills.**Required Education & Experience**Bachelor’s degree in biomedical engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of six (6) years of relevant industry experience OR a master’s degree in the same fields with a minimum of four (4) years of relevant industry experience (e.g., pharma, biotech, medical devices).Hands-on experience with medical device testing and development, particularly in test method development, test method validation, and design verification.
Familiarity with FDA regulations, cGMP standards, and design control for medical devices. Experience with relevant statistical techniques (e.g., Gauge R&R, normality testing, data transformations, statistical sampling and sample size calculations, ANOVA).
**Preferred Experience** Experience leading combination product testing projects and familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369). Proficiency in CAD software (e.g., SolidWorks, OnShape) and 3D printing for prototyping and fixture development. Experience with technology transfer and scale-up of combination product testing methods.
Experience with statistical software (e.g., JMP, Minitab). #J-18808-Ljbffr
We are seeking a highly motivated and detail-orientated **Specific Responsibilities** **Knowledge & Skills** Strong verbal, written, and interpersonal communication skills.**Required Education & Experience**Bachelor’s degree in biomedical engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of six (6) years of relevant industry experience OR a master’s degree in the same fields with a minimum of four (4) years of relevant industry experience (e.g., pharma, biotech, medical devices).Hands-on experience with medical device testing and development, particularly in test method development, test method validation, and design verification.
Familiarity with FDA regulations, cGMP standards, and design control for medical devices. Experience with relevant statistical techniques (e.g., Gauge R&R, normality testing, data transformations, statistical sampling and sample size calculations, ANOVA).
**Preferred Experience** Experience leading combination product testing projects and familiarity with relevant ISO standards (e.g., ISO 11040, ISO 11608, ISO 80369). Proficiency in CAD software (e.g., SolidWorks, OnShape) and 3D printing for prototyping and fixture development. Experience with technology transfer and scale-up of combination product testing methods.
Experience with statistical software (e.g., JMP, Minitab). #J-18808-Ljbffr