Senior Production Engineer — Medical Device Manufacturing

Title: Production Engineer III, Manufacturing Location Onsite Status Type Full Time Qualifications Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or equivalent education/experience Minimum of 4 years of experience in FDA regulated manufacturing and/or process/equipment/product development Beginning experience leading cross-functional teams, projects, and/or direct reports Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing Preferred Qualifications Experience in a high-volume FDA regulated commercial manufacturing environment Lean Six Sigma Green or Black Belt Certification (LSSBB/GB) Skills & Competencies Strong attention to detail and commitment to quality Excellent verbal communication and technical writing skills Ability to troubleshoot equipment and processes using investigation techniques (5 Why’s, Fishbone Diagram, etc.) General knowledge and understanding of automation: vision systems, robotics, and PLCs Understanding and application of 21 CFR 820 Medical Device Quality System Regulation relevant to manufacturing support Proficient with the MS Office Suite (Word, PowerPoint, Excel, Visio) CAD or AutoCAD design and drafting skills Ability to plan and carry out sequential projects independently Ability to analyze problems and troubleshoot solutions effectively Ability to foster teamwork, collaboration, negotiation, and influencing others at the project team level Ability to adapt behaviors and activities during times of change and handle unexpected situations with minimal guidance Exemplifies flexibility and resourcefulness in responding to challenges and opportunities Strong time management skills and ability to manage multiple priorities Ability to maintain a positive attitude, show empathy for others, and act with integrity in support of company goals and a healthy work environment Physical Requirements Must be able to remain in a stationary position for extended periods of time Ability to constantly operate a computer and other office equipment Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time Ability to lift 50 lbs Responsibilities Manufacturing Support: Respond rapidly to downtime events and support efforts to bring production back online as quickly as possible Continuous Improvement: Identify opportunities to improve yield/throughput/labor and begin leading implementation with guidance Quality System Documentation: Author documents such as NCRs, CAPAs, change controls, and rework instructions; present at cross-functional review boards; author/revise DCOs and routers in SAP Root Cause Investigations: Support product/process/equipment investigations with cross-functional teams Production Model: Create and maintain labor/capacity/yield models for manufacturing lines Engineering Builds: Support development builds; write engineering reports to summarize builds Build Protocols and Reports: Author build protocols and reports Training: Act as approved trainer for manufacturing operators Layout/Workflow: Participate in efforts to optimize layouts and workflows using lean methodologies Other duties as assigned Nearest Major Market Cincinnati #J-18808-Ljbffr Enable Injections, Inc.