| Location | Aliso Viejo, CA |
Responsible for supporting medical devices for both existing and new product development, production, and processes. This includes creating or verifying specifications, maintaining and enhancing product processes, designing fixtures and equipment, testing processes, equipment, test methods, and raw materials to ensure that the concepts and prototypes meet their specifications. Support projects related to new product introductions, process development engineering, quality systems improvement, and other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation.Job DutiesSupport new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixturesDraft and execute validation of product, equipment, and processesProvide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and qualityLead builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planningAnalyze data and improve processes to assure robust/repeatable manufacturing processesConfer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processesSupport projects related to process validation and product transfer activities across different manufacturing facilities and product linesDevelop manufacturing documents (e.g., MP, Routers, BOM, Drawings, Specifications, etc.)Develop and maintain project timelines, milestones, and deliverables to ensure smooth execution of the NPI processCollaborate with the quality team to establish testing and inspection protocols toensure the final product meets quality standardsCollaborate with design engineers to optimize product designs for efficient manufacturing and assembly processesReview product designs to identify potential manufacturability and assembly issues, providing recommendations for improvementsComply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organizationPerform additional duties as assignedJob ID 13724BRSalary Range: $75,937-$99,667. Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.#J-18808-Ljbffr