Medical Device Engineer

617633Our client, a leading Biotechnology company located in Thousand Oaks, CA, is looking for a Medical Device Engineer to participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.Required Skills:Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)Understanding of Mechanical Design Engineering ConceptsExperience with Final Drug Product andor Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)Experience with design controls; including (but not limited to) design verification and transferUnderstanding of risk assessments including hazard and probability analysisExperience with investigations and quality recordsLaboratory and electronic lab notebook experienceStatistical Analysis software (Minitab or JMP)Responsibilities:Adheres to strict documentation practices in a GMP regulated environmentEngineering competency in all conventional aspects of the subject matter, functional area, and assignmentsPlans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.Authors and reviews technical documentation including protocols, reports, and technical assessmentsCoordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish effortsAnalyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisionsMaintains device and combination product design history files for assigned productsEnsure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errorsProvides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessmentsProvide general laboratory support including inventory management, sample shipments, and cleanup.Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications***Compensation within this range will be commensurate with level of experience***

Created: 2025-02-09