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.