Senior Manufacturing Engineer
On-siteBall Ground, Georgia, United States
Job Summary
Plan, organize, and implement systems and procedures for MVE product manufacturing while enhancing flow and applying Lean concepts. Conduct and supervise studies to determine causes of quality deviations and analyze workflows to improve efficiency. Partner with Design Engineering for new product introductions and perform qualification and validation activities for new equipment and processes. Resolve assembly errors by applying formal problem-solving tools like 5 Why's and 8D. Manage capital equipment projects to ensure on-time delivery within budget constraints. Perform hands-on mechanical and electrical troubleshooting of production equipment, including PLC diagnostics. Observe and promote safety policies in both office and production environments.
Required Qualifications
- BS degree in Engineering, preferably Manufacturing, Mechanical or Industrial
- 3 –5 years of relevant Medical Device Manufacturing experience; or a minimum of 10 years of experience in a related field
- Experience must reflect increase in scope and complexity of duties and responsibilities
- Six Sigma Black Belt certification required
- proven track record of leading and delivering measurable process improvement projects
- Must possess a working knowledge of computers, including MS Word, Excel, and SolidWorks
- General familiarity of medical device or similar quality systems requirements
- Understanding of MIG/TIG welding practices, sheet metal fabrication, cryogenics, and vacuum systems
- Understanding of factory metrics, Lean (Operational Excellence) and Six Sigma
- Knowledge and understanding of company safety procedures and policies
- Awareness and understanding of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 13485, MDD/MDR, FDA
- Team player mentality with a passion for, and alignment with, MVE's mission
- An individual who brings strong core values, quality, ethics, and integrity
- A team player who embraces and champions the culture of collaboration and accountability
- Strong work ethic and ability to deliver results and meet commitments in a dynamic environment
- Exceptional and dynamic communication skills with the ability to inspire and influence others
- An individual who works efficiently, effectively prioritizes and drives towards our corporate goals
- Exceptional organizational and planning skills, strong analytical abilities, and process orientation
- Demonstrates a business process orientation to developing solutions
- Ability to work in both an office and production environment
- Occasional travel to customers, vendors, or other MVE locations is possible
- Ability to sit, stand, and/or walk for 8 hrs/day
- Occasional lifting of up to 30 lbs., occasional heavier lifting
- Occasional pushing, pulling and handling of materials
- The ability to move around the production floor and lab areas to address production issues relating to products and equipment
- Working with cryogenic products will involve possible exposure to pressurized flammable gas, pressurized oxidizing gas, pressurized inert gas and very low temperatures (-320o F)
Desired Qualifications
- Understanding of MIG/TIG welding practices, sheet metal fabrication, cryogenics, and vacuum systems, a plus
- Understanding of factory metrics, Lean (Operational Excellence) and Six Sigma, a plus
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