R&D Product Development Eng - (Un-CA-Santa Barbara - 93199)

Minimum Education: Bachelors
Jobcode: 195528
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PRODUCT DEVELOPMENT ENGINEER- Santa Barbara, CA Medical device manufacturer needs combination of product development and manufacturing engineering experience with medical products.Hands on mechanical product design & product development role.Duties: Plan, design and develop new, existing or modified product concepts from R&D development lab into production. Project Leader responsibilities. Leads projects for one or more product development projects for medical devices to achieve on-time results and according to plan. Provides technical input for projects at all stages of the product life cycle. Take customer concepts & conducts design verification at various stages of the design process to ensure consistency between the outputs against the requirements Project management & documentation with design controls, risk analysis, etc in accordance with established SOPs. Creates performance and functional requirement specifications to comply with ISO standards Prepares design layouts and detailed drawings in support of assigned technical activities relating to customer application. Assesses new technology and new product ideas for technical and economic feasibility, best practices and methods and latest materials. Designs test apparatus, equipment and develop procedures for testing products including acceptance and rejection criteria Builds and tests prototype devices. Selects materials for medical devices Provides engineering support for products launching to production and resolve issues as they arise. Incorporate required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File. Responsible for product prototyping and process troubleshooting. Responsible for documentation (including development of the Design History File and related records.) Develops project plans and timetables for assigned projects. Execute project plans in the development of new, existing or modified products. Maintain and report recommendations on new technologies, customer needs, and business developments in competitive markets.Requirements: 4 year degree in Engineering-BSME or BioMedical. 5-10 years medical device products-engineering resins. FDA & ISO13485. Solid product design and product development experience with injection molding. from concept, thru design, scale up and onto production. AutoCad-SolidWorks. Sustaining engineering practices, product safety and root cause analysis. Knowledge of GMP for tooling, molding, design and process methods. Experience working with R&D for rapid prototyping, material selection, product design and process specs. LabView testing experience desired. Statistical analysis (Minitab). Good product/business cost knowledge and strong communication skills. Strong computer skills, spreadsheets, statistics and project scheduling. MS Project.