Principal Manufacturing Engineer

Company: Sonendo-- -, Inc.
Location: Laguna Hills
Posted on: November 13, 2019

Job Description:

Sonendo, Inc. is a privately held, venture-backed company developing innovative technologies to transform dentistry by Saving Teeth Through Sound Science -. We are currently building a high-performance team with a passion for creativity and innovation. We believe our success is based on always being at least one step ahead of our competitors, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision. Responsible for leading engineering projects as they relate to Sonendo's product and process development activities. Works closely with product development teams for both capital and disposable medical devices and manage products through all stages of its product life cycle. This position will work cross functionally with other functions of Sonendo's organization to achieve key strategic objectives. Lead cross-functional project teams as assigned. Responsibilities Support design and development of new products at both the system and component level as it relates to manufacturing Participate in design reviews during the product development cycle to ensure designs are capable to meet full scale production Ability to persuade and inform engineering teams to implement changes for design for manufacturability Provides manufacturing engineering support for complete integration of new products into full production Ability to use Design for Six Sigma Methodology to drive improvements for manufacturability in new product development Initiate, prepare, conduct and document formal qualification and validation Initiate, design and build test fixtures to test or evaluate components and systems for line set up Ability to determine root cause of failure investigations and implement solutions using risk-based decision making Ability to use lean manufacturing practices and six sigma methodology to evaluate and improve assembly line and product performance Ability to work with suppliers on key component issues as it relates to manufacturing to implement process controls Initiates and prepares project feasibility studies, prepare timelines, manage and execute to timelines Ability to produce progress reports to inform management of project status Ability to work cross functionally and communicate effectively, verbally and written to a broad audience Identify potential medical device hazards and assist with maintaining Risk Management files Deliver medical device design documentation compliant with FDA design controls and good documentation practices including creating and maintaining medical device Design History Files and Device Master Records Qualifications Requires a BSME or equivalent with 12 years of experience. Medical device manufacturing experience essential; plastic part assembly, metal machining, fluidics knowledge, low volume - high pressure fluid systems desirable. Experience in Product development and product transfer is preferred Knowledge of ISO, FDA, UL and CE requirements as they relate to manufacturing. Proficient with Solidworks, Minitab or equivalent, Microsoft Project, PowerPoint, Word and Excel. Proficient knowledge in applying Statistical Analysis such as, but not limited to: Process capability Hypothesis Testing Anova Process Capability GR&R DOE Proficient experience in applying DFSS/Lean Six Sigma elements into Manufacturing problems Knowledge of machine shop practices desirable Must be a hands-on problem solver. Must have demonstrated cross-functional team effectiveness, excellent interpersonal and written communication skills

Keywords: Sonendo-- -, Inc., Cypress , Principal Manufacturing Engineer, Engineering , Laguna Hills, California