Production Engineer III, Manufacturing

Enable Injections Inc.•Sharonville, OH

17d•Onsite

About The Position

QUALIFICATIONS Required: 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: 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 operate a computer and other office equipment for extended periods of time Ability to lift 50 lbs. Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time Position requires being physically present on the premises during regular company hours or as approved by management

Requirements

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
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
Must be able to remain in a stationary position for extended periods of time
Ability to operate a computer and other office equipment for extended periods of time
Ability to lift 50 lbs.
Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time
Position requires being physically present on the premises during regular company hours or as approved by management

Nice To Haves

Experience in a high-volume FDA regulated commercial manufacturing environment
Lean Six Sigma Green or Black Belt Certification (LSSBB/GB)

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