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.