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Sr. Manufacturing Engineer
| PostId | 7bbfce4a-43e9-4e63-a4b0-798dba43eaa6 |
| Posted Date: | 5/19/2010 |
| Job Category: | Manufacturing |
| Salary Range: | DOE |
| Location: | Bay Area (South Bay) |
| Description: | POSITION: Sr. Manufacturing Engineer DEPT: Manufacturing REPORTS TO: Manufacturing Engineering Manager LOCATION: South Bay STATUS: Public General Summary: The Sr. Manufacturing Process Engineer will be responsible for designing and implementing new processes to manufacture high quality medical devices and associated accessories. The Sr. Mfg. Process Engineer will use a variety of tools to continuously improve existing manufacturing. The Sr. Mfg. Process Engineer will work to standardize manufacturing processes and put appropriate controls in place to monitor status. They will also interact with design engineers and be responsible for leading product transfer involving process capability, DFM, and operator training. Essential Functions: • Optimizes manufacturing processes to provide sustainable gains in gross margin and product performance through capital projects, statistical analysis, designed experiments, procedural changes, simulation and modeling • Provides on-going technical support to production line for equipment, process, or design related issues • Monitors process and equipment performance; identifies and implements process improvement activities to increase/optimize yield, efficiency or throughput. • Maintains safety, product quality, and manufacturing effectiveness by examining equipment, processes, operations, product components and assembly to determine time or quality revisions and suggests/implements improvements • Works with suppliers and participates in multi-functional teams to resolve technical/quality issues and develop new products • Participates in new product design and development reviews; suggests ways to enhance DFM; develops process FMEAs; leads transfer of products from design to production; supports product scale-up activities • Drives a Lean culture of continuous improvement; leads and participates in Kaizen events; promotes 5s activity to standardize work; works with manufacturing manager to establish takt time to maximize throughput, reduce cycle time, identify constraints and balance work content; creates and updates value stream maps • Specifies, evaluates, selects, and implements new equipment and fixtures; develops and executes installation, operation, and performance qualification protocols • Designs and implements validation protocols for process improvements and material changes including comprehensive engineering reports providing analysis of results • Develops efficient, effective systems for capturing critical process metrics for all manufacturing operations; implements automated data collection where possible Skill Requirements: • Experienced in designing and performing process validations • Strong analytical skills and common sense with emphasis on a scientific method of problem solving • Able to model and simulate manufacturing flows • Motivated self-starter, able to accept and produce timely results on multiple concurrent projects of significant complexity • Works well in dynamic, cross-functional team environment; consistent positive attitude; motivates others by example • Analyzes complex situations; extracts, summarizes and communicates key information effectively to team members/superiors in decision-making situations • Able to write clear, concise and visual work instructions • Possess effective verbal and written communication and interpersonal skills to interact with associates at all levels of the organization • Knowledge of design controls, FDA and MDD requirements; able to work within a medical device quality management system • Ability to multi-task and prioritize responsibilities to ensure deadlines are met in a fast-paced environment • Has project management skills sufficient to take a proposed solution from resource appropriation through project scheduling and execution as well as being able to work as part of a decision making team to bring about positive change • Has a fundamental drive for continuous process improvement Education/Training/Experience Requirements: • BS/MS in industrial engineering or other technical degree with equivalent experience • Minimum of 5 years experience in a commercial manufacturing environment driving continuous improvement Preferred Experience: • Medical device manufacturing • Applied Lean (Toyota Production System) techniques • Production of electromechanical assemblies • Production of intravenous catheters involving tip bonding, pad printing, balloon bonding, coating, and packaging/sterilization • Ultrasonic welding of plastic enclosures |