Senior R&D Engineer - New Product Development!
The Senior R&D Engineer - New Product Development will be a part of the Research and Development team and report to a Research and Development Manager. The Senior R&D Engineer - New Product Development will perform job responsibilities with limited supervision.
This role is primarily focused on the development and support of electromechanical medical products at Company, focusing on Cardiac. The Senior R&D Engineer - New Product Development will provide technical leadership for research projects, as well as product development projects. This individual will lead both internal engineering teams and external contract engineering teams. Occasionally this individual will conduct individual measurement and analysis of existing devices, as part of product validations, product evaluations and product investigations.
The Senior R&D Engineer - New Product Development will be a lead participant in project development core teams as the R&D representative and/or technical lead. This individual is responsible for writing and defining product specifications and requirements, product architecture and design, product performance and usability. This individual will be planning and leading design and development projects, as needed. S/he will be planning and conducting device verifications and validations. This individual will be leading and performing in-depth technical design reviews. S/he will perform failure analysis and investigations. S/he will be performing measurements, creating engineering designs, developing plans and keeping laboratory notebooks on all work. This individual will be leading and conducting tests (Bench, V&V, in vivo), developing and utilizing test protocols and generating written reports. S/he will be recommending and enforcing design for compliance to applicable standards for medical devices.
The Senior R&D Engineer - New Product Development will serve as an engineering subject matter expert to support multiple projects and cross functional teams. This individual will act as liaison between external vendors and the product development core team. S/he will mentor junior engineers to develop technical skills as well as influence skills (to be used with both sub-contractors and internal development core teams). S/he will travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities. S/he will be re responsible for communicating business related issues or opportunities to next management level. This individual is responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
The ideal candidate will have a minimum of a Bachelors degree in an engineering discipline with a minimum of 5 years of related experience and/or training; or equivalent combination of education and experience is required. An advanced Degree with a minimum of 3 years of related experience and/or training is preferred. Hands on experience in medical device design including technology or product development responsibility is a plus. Experience in leading technical projects is also preferred. The successful candidate must have experience in development processes and in documentation writing. The successful candidate must be familiar with design control, engineering change orders (ECO), and Corrective Actions and Preventive Actions (CAPA). Knowledge and experience with RF systems or catheter design is a plus. The successful candidate should have the knowledge, skill and ability to provide technical leadership on cross-functional teams. Excellent communication skills and the ability to express complicated technological ideas in layman terms are required. The Senior R&D Engineer - New Product Development will be expected to have strong analytical reasoning. Ability to mentor and guide junior associates is required. Problem solving capabilities is strongly preferred. The successful candidate should be a self-driven individual who is capable and excited to learn about new technologies. This position is located in San Gabriel, CA and may require up to 20% international/domestic travel.