Manufacturing Project Engineer : 26-02107

Key Responsibilities:

• Drive process improvements to boost operational performance and reduce waste.
• Exercises knowledge of Lean/6σ principles in manufacturing by performing Gauge R&Rs, DOEs, etc.; utilizes methods such as 5S, Kaizen, Kanban, OEE, Value Stream Mapping, root cause analysis, SMED, statistical control, etc.; and performs design and process risk assessments (FMEA).
• Initiates, develops, recommends, implements, and evaluates engineering methods and procedures to optimize existing manufacturing and infrastructure processes (i.e., keep facility operational and efficient, improve operating performance, eliminate waste, reduce cost, reduce cycle time, maximize flexibility, meet production goals, ensure quality, improve customer satisfaction, etc.).
• Qualifies and validates equipment in an FDA regulated industry by commissioning/managing/generating/executing qualification and production documentation (ie, SOP, WI, URS, FAT, SAT, IQ/OQ/PQ, gap analysis, etc.) for equipment and facility projects.
• Manage diverse engineering projects, including cost estimation and milestone tracking.
• Troubleshoot manufacturing and equipment issues through cross-functional collaboration.
• Coordinate new equipment and process launches, including comprehensive team training.
• Apply Lean and Six Sigma principles to optimize manufacturing operations.

Must-Have Skills:

• Proficiency in Kaizen and Lean manufacturing techniques.
• Minimum 7-10 years experience in manufacturing engineering.
• Bachelors degree in Mechanical Engineering required. Masters degree preferred
• Proven ability in complex problem-solving and analytical design.
• Strong project management skills with a focus on forward planning.

This role requires experience within an FDA-regulated manufacturing environment, specifically involving qualification and validation of equipment and facilities.