Engineer Senior, Drug Delivery Devices/Development & ...

OverviewJob Title: Engineer Senior, Drug Delivery Devices/Development & Commercialization (JP13860)Location: Thousand Oaks, CA. 91320 (Hybrid)Business Unit: Prefilled Syringes & Kit PlatformEmployment Type: ContractDuration: 1+ year with likely extensions and/or conversion to a permanent position.Rate: $45 - $50/hour W2 with benefitsPosting Date: 05/1/2025Notes: Only qualified candidates need apply. Onsite in Thousand Oaks, CA - 2-3 days per week onsite.Job DescriptionThe Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.The ideal candidate will have a B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal. Nice to have: experience working on prefilled syringes or vials; combination product experience; regulatory experience.Top Must Have Skill SetsPharma background.Physical testing experienceDesign controls experienceDay to Day ResponsibilitiesLeading test procedure development and functional test executionLeading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groupsAuthoring technical plans and reportsPerforming advanced statistical data analysisSupporting leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team membersTransfer of information to manufacturing sites, engagement with suppliersMaintenance of Design History File content consistent with Good Documentation PracticesTraining junior staff on physical test methods, sample preparation protocols and procedures, and effective report writingReviewing primary data collected from peers in support for various design controls activities, including characterization and design verificationSupporting design transfer activities by leading cross-functional coordination of sample procurement and testingSupporting the setting of specification limits for platform devices through human factors studies benchtop testingEssential SkillsDoctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experienceFully competent engineer in all conventional aspects of the subject matter, functional area, and assignmentsPlans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challengesGenerates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.System level root cause investigation; CAD/SolidWorks proficiency; tolerance analysis; capability analysisCoordinate and implement design improvements with development partnersCollaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specificationsAccountability of maintaining technical records within product design history filesIndividual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organizationWorking proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971)Preferred QualificationsDegree in Mechanical or Biomedical Engineering, or related fieldMedical device industry and/or regulated work environment experienceExcellent written and verbal communication skillsUnderstanding and experience in: development/commercialization of medical devices and knowledge of manufacturing processes; initiating and bringing complex projects to conclusion; ability to work independently and in dynamic cross functional teams; design controls; failure investigation; applied statisticsRed FlagsPoor communication skillsLack of hands on testing experienceWhy is the Position Open?Planned ProjectInterview ProcessOne round of interviews.We invite qualified candidates to send your resume to . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr

Created: 2025-09-17