Contractor | IT Outsourcing & Consulting2 Weeks Ago
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Talent Software services is Hiring an Engineer - R&D Engineer III Near Santa Clarita, CA
Job Description: Hybrid About The Role" Provides engineering support for integration activities for an acquisition. " This position is a contract role, expected to complete by the end of July 2025. " Provides oversight of the design, quality, manufacturing, and project related activities. " Coordinates with internal functions and external suppliers to identify and execute projects. " Applies project management and problem solving skills to manage multiple activities concurrently. Develops products, materials, processes, or equipment for projects of moderate complexity. Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials. " 5 - 15% domestic travel possible Your Responsibilities Include" Ensuring all Design Controls aspects of an acquisition are remediated through:
Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing
" Supporting manufacturing moves from one vendor to another. " Supporting project work for EUMDR approval. " Maintains product safety, quality, and compliance of all products. " Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP). " Supports any applicable R&D project planning and activities. " Understands and complies with all the regulations governing the quality system. " Supports additional activities required by the business. What We're Looking For" 2 years working with design controls. " 2 year of project leader/manager experience. " 2 years working within FDA Quality System Regulations and ISO 13485. " Experience with assessing quality and compliance impact on products for design and process changes. " Experience with design verification and validation activities. " Experience with Test Method development. " Experience in troubleshooting and root cause analysis. " Self-motivated individual who can work independently. " Working knowledge of MiniTab and SolidWorks. " Good writing (assessments, protocols, reports, and email) and verbal communication skills. Preferred Qualifications" Has led 4 projects to drive product design changes or process changes preferred. " 3 years of Electro/Mechanical experience. " Has participated in 4 new product development projects, related product transfer and scale-up activities preferred. " Knowledge of manufacturing processes including; silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing and packaging. " SAP and Windchill experience is a plus. " Human Factors / Usability experience is a plus. Quality Systems Duties And ResponsibilitiesBuild Quality into all aspects of their work by maintaining compliance to all quality requirements. Qualifications5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD