Ormco Senior R&D Mechanical Engineer II (Pomona, CA)

United States of America, California, Pomona R5027741 United States of America Engineering Job description JOB SUMMARY: The Senior R&D Mechanical Engineer II is a highly creative and technically strong mechanical design engineer with a demonstrated ability to translate unmet customer needs and early-stage concepts into commercially viable medical devices. This individual combines innovation, hands-on engineering, and strong business awareness with exceptional communication and collaboration skills. They are self-motivated, intellectually curious, comfortable operating in ambiguity, and capable of independently driving projects from concept generation through commercialization while influencing cross-functional teams across R&D, Manufacturing, Quality, Regulatory, Marketing, and Supply Chain. The selected candidate must reside within a commutable distance to Pomona, CA. This is not a hybrid or remote opportunity and requires onsite presence 4 days per week. PRIMARY DUTIES & RESPONSIBILITIES: Responsible for development of next generation/breakthrough orthodontic products. This includes translation of emerging technologies to prototypes and ultimate products. Subject Matter Expert (SME) in either orthodontic fixed appliances or aligners. Lead or support multiple product development projects as needed beyond SME. Participate in design reviews and collaborate with engineers to verify and validate designs. Work and collaborate with cross-departmental engineers to develop test protocols, reports, and risk assessments. Work with the R&D, Procurement and Manufacturing teams to identify, evaluate and qualify suppliers and raw materials as required for new product development (NPD) and establish instructions, processes and plans to transition projects from R&D to Manufacturing Serving as the technical advisor to manufacturing, QA and procurement staff for raw material requirements, vendors, developing material test protocols and fabrication processes Ensure test equipment meets all safety, quality, and efficiency standards through IQ, OQ, and PQ before released to production. Research, suggest, and/or implement new materials that can improve product’s performance. Leverage automation tools to streamline manufacturing processes. Prepare advanced technical reports and white papers. Summarizes and communicates data of a complex nature to non-technical audiences. Able to lead to small intermediate projects with minimal supervision; is accountable for results and owns the data. Design and carry out experiments with scientific methods. Hypothesis to Conclusions reporting. Analyze and understand market and technology trends. May support all phases of product development including manufacturing scale, design control, packaging, documentation, risk assessments, product performance verification, end user validation and commercialization. Will interface with various customer personnel and internal Product Management to determine both articulated and unarticulated needs to develop products that meet/exceed customer needs while maximizing value in use. Conduct feasibility studies and provide constructive feedback on prospective projects/technologies. Plan schedule of research according to project schedule and establish daily or weekly routines accordingly Develop in-depth knowledge of new and existing products. Train and supervise other research staff. Evaluation of ideas, patents and emerging technologies. Up to 10% travel may be required. Job requirements Bachelor's degree in Mechanical Engineering from a credited university. 7+ years of progressive mechanical engineering and product development experience, preferably within the medical device or other highly regulated industry. Extensive hands-on mechanical design experience, including concept generation, mechanism design, material selection, tolerance analysis, design optimization, prototyping, and design for manufacturability and assembly (DFM/DFA). Generate novel product concepts and rap…

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