R&D Engineer

R&D Engineer Location: Irvine, CA Schedule: Standard Duration: 12 Month Contract Pay Range: $38.50-43.50/hr Our client, a leading medical device company, is seeking an R&D Engineer to support its transcatheter aortic valve therapies. This role leads and supports key projects for commercialized THV products, including product configuration changes, design control support for supply-chain driven manufacturing improvements, investigations into field performance issues, and labeling and training updates tied to global therapy expansion. Job Responsibilities: In this role, you will manage and support a variety of projects within the commercialized product R&D engineering department. Key responsibilities include: Providing engineering input to commercialized THV product projects, including application of design control and risk managementDeveloping solutions to problems of moderate scope and complexityServing as a subject matter expert on field performance of THV devices and the design features tied to key performance metricsSupporting product configuration changes, supply-chain driven manufacturing improvements, field performance investigations, and labeling and training updatesEssential Job Duties and Job Functions: Apply mechanical and biomedical engineering principles to the design and development of delivery system components and accessoriesWork across a broad scope of projects, including material changes, manufacturing improvements, packaging and labeling changes, and instructions for use and usability changesDevelop test methods and procedures to evaluate device prototype performanceAssign support tasks, give instruction to technicians on conducting tests, train technicians and provide feedback, and coordinate technician work as neededBuild partnerships with key cross-functional stakeholdersMaintain accurate documentation of concepts, designs, drawings, and proceduresGenerate written protocols, reports, and technical justifications/summariesPerform other incidental duties assigned by leadershipKnowledge and Skills: Experience with design controls, design verification and validation, or design test method developmentDemonstrated experience reviewing and updating risk management documentsExperience using statistical techniques to support design decisions and product acceptance testingEffective verbal and written communication, listening, and diagnostic skillsCollaboration and influencing skills to achieve results with cross-functional teams and stakeholdersAbility to work independently and as part of a team, including inter-departmental teams, and to act as key contact representing the organization on contracts or projectsStrong problem-solving, organizational, analytical, and critical thinking skillsGood leadership skills and ability to influence changeKnowledge of design control and design change for product improvementsExperience with sustaining activities for commercialized productsWorking knowledge of statistical techniquesExperience with test lab equipment (if applicable)Knowledge of applicable FDA regulations for the medical device industry desirableDesign for Six Sigma or Lean Six Sigma certification (Green Belt or Black Belt) preferredEducation and Experience: Bachelor's degree in an engineering or scientific field plus 4 years of quality engineering experience, OR Master's degree in an engineering or scientific field plus 3 years of quality engineering experienceLife sciences industry experience (medical device, pharma, or biotech)Experience in new product development, with successful design experience from concept to commercialization, strongly preferredMaster's degree in engineering, science, or a related discipline preferredMedical device industry experience highly preferredCatheter-based therapy experience preferredStrong experience in quality engineering, R&D, or manufacturing engineering preferred ...