R&D Engineer - Medical Device (W2 Only)

W2 Only, no C2C or 3rd party candidatesPotential for conversion to perm depending on performanceR&D ENGINEER IISUMMARY:R&D Engineer needed to provide support and guidance for medical device design and development activities for a thriving medical device organization.DUTIES & RESPONSIBILITIES:Provide input, guidance and support for product concept and design, development, prototyping, manufacturing and testingSupplier management related to materials and components, quality inspection and resolution, etc.Design and execution of relevant tests such as Design Verification and Validation, DOEs, animal/bench testing, Test Method Validation, Process Validation and relevant data collection, analysis, reporting and documentationSystem Integration, Design Control, Engineering Analysis, Coordinating of Usability/Human Factors and Clinical testing, and additional development activitiesRegulatory, Quality Systems, and ISO ComplianceMay provide mentorship, training, supervisory and/or leadership supportOther duties, as requiredQUALIFICATIONS & REQUIREMENTS:3+ years of relevant experience in medical device (catheter-based preferred) research and development, including a good understanding of related regulatory, Quality Systems and ISO complianceProven technical writing experience (component specs, Manufacturing Process Instructions, protocols, reports, etc.)Proven software proficiency in MS Office and SolidWorks, and statistical analysis using Minitab and/or MS ExcelGood understanding of Design Control processes and compliance and Risk ManagementExperience with V&V and related data collection, analysis, documentation and reportingRelevant BS DegreeLOCATION:Work will be performed onsite in the greater San Jose Area.

Created: 2025-01-15