Sr Manufacturing Engineer
Orange County Metro Area, CA
Sr Manufacturing Engineer
Medical Device Industry
Laguna Hills, CA
Essential Duties and Responsibilities:
Responsible for leading engineering projects as they relate to our 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 our organization to achieve key strategic objectives. Lead cross-functional project teams as assigned.
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
Education and/or Work Experience Requirements:
Requires a BSME or equivalent with 5-8+ 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:
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Position is primarily sedentary and employee may be required to sit for extended periods of time. Standing, walking and meeting activities are required frequently throughout the workday. Employee must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.). A large portion of the day is spent communicating orally in person and by phone. Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.