Senior R&D Engineer
Senior RD Engineer - Interventional Oncology
Senior RD Engineer - Interventional Oncology The Sr. Engineer will be responsible for the product design and development aspects of complex systems with a focus on innovative mechanical devices that address the customer needs for a complete procedural solution. The candidate will work closely with members of the project core team (marketing, manufacturing, quality, and regulatory) as well as interface directly with customers key opinion leaders. Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. Key Responsibilities: Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment. Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation. Selects techniques to solve complex problems and make sound design recommendations. Summarizes, analyzes, and draws conclusions from complex test results using valid statistical techniques. Designs and prepares complex reports to communicate results to technical community. Designs and coordinates complex engineering tests and experiments. Coordinates, manages, and documents project goals and progress and recommends appropriate revisions. Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment. Interfaces with Physicians/ IR Lab personnel to obtain feedback on concepts and performance of new devices. Translates customer needs into product requirements and design specifications. Responsible for engineering documentation Works cooperatively with external development OEM partners, process development, quality, OEM/internal manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success. May train and/or provide work direction to technicians and entry-level engineers. Demonstrates PDP/TDP system knowledge through delivery of high quality and high impact deliverables Ability to lead technical projects and lead technical teams in solving challenging problems in the creation of new medical devices. Considers mechanical engineering principles in product design/development and ensures compliance to applicable IEC standards Some domestic and international travel to vendors, manufacturing facilities, and medical conferences. Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements Prepare design /engineering documentation aspects in support of FDA submissions