Manufacturing Engineer

Description:

This position is responsible for leading as a central resource for Manufacturing and assists with day-to-day

production support and improvements. Responsible for managing all activities for sustaining engineering

philosophy, productivity and safety advantages, environment and implementation.

• Ensure QA compliance within regulatory standards such as FDA and ISO 13485, while achieving production Key Performance Indicators (KPIs).
• Lead concurrent engineering practices with Engineering to successfully transfer New Product Introductions (NPIs) within manufacturing.
• Perform/complete supplier qualifications, which includes, but not limited external process capabilities studies.
• Perform/complete process IQ/OQ/PQ qualifications, which may include PPQ validations.
• Review, create, revise, etc. manufacturing documentation (i.e. drawings, Work Instructions, Batch Records).
• Execute LEAN manufacturing techniques and principles, but not limited to:
• Must be a team player and understand motivating team members into a LEAN environment.
• Facilitate a “self-directed” manufacturing environment.
• Minor design/development of manufacturing fixtures and equipment.
• Identify manufacturing cost reductions and provide ROI justifications for change.

Requirements:

Bachelor's degree in Manufacturing, Mechanical Engineering, or equivalent with minimum of +5 years of proven

experience in ISO 13485 production environment is required. Green Belt certification in Six Sigma and/or Lean

Manufacturing preferred.

Required Skills:

• Self-motivated to accomplish goals and objectives with little supervision.
• Multi-tasking skills are required to manage multiple projects and various project activities.
• Strong communication, presentation, and interpersonal skills are needed to interact with all areas of business and internal/external customers.
• Strong analytical and technical skills are needed for all product support activities.
• Strong computer skills, including knowledge of SolidWorks required.
• Ability to understand production processes and should be aware about the product operations.
• Ability to follow all the internal, FDA’s GMPs, and ISO quality standards guidelines strictly.