Manufacturing Engineer

Description

• Adheres to all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Creates and implements lean processes in a cellular environment utilizing appropriate methods such as CNC turning and milling, Wire EDM, Laser Etch, Laser and TIG welding, Polishing, Mass Finishing, Cleaning, Assembly, and Inspection.
• Defines, produces and implements documents including standard work and process work instructions.
• Identifies, develops, justifies, and executes detailed project plans for engineering work with minimum supervision.
• Ability to launch new products effectively in a contract manufacturing environment.
• Investigates, develops and implements new process technologies.
• Successfully communicates complex issues with customers and internal team members.
• Creates, reviews and approves engineering drawings, equipment layouts, change orders and specifications.
• Develops tooling, fixtures and equipment used in manufacturing to optimize productivity and cost.
• Effectively owns and manages CAPAs pertaining to their areas of responsibility.
• Collaborates with development, programmers, machinist and suppliers to evaluate designs for manufacturability and cost reduction.
• Creates and executes validation protocols, processes and material evaluations.

Education/Certification

• Engineering or Bachelor’s degree in a technical field with applicable experience is not required. Lean or Six Sigma certification preferred.

Skills/Competencies

• Strong problem solving skills.
• Ability to provide solid rational and justification for process improvement change requests
• Lean manufacturing and new product development or launch support experience is highly desirable.
• Understanding of metals machining, processing, and polishing is strongly preferred.
• Ability to work in a team environment.
• Strong written and oral communication skills.
• Experience in medical devices preferred.