Experience Requirements
Minimum of 2 years of medical device experience
Minimum of 2 years of manufacturing engineering or process development
The ability to work within an organization and across functional boundaries to get programs accomplished within the quality and manufacturing guidelines at our facility.
The ability to manage Cost Improvement Programs across multiple projects is required.
Working knowledge of manufacturing processes related to catheter production, molding, and extrusion is required.
This individual must have a track record of project management, problem solving, solid decision-making and project completions.
Qualification Requirements
Must have a 4 year Technical Degree.
Preferred Qualifications
Minimum of 2 years of catheter manufacturing and process development is desirable.
Responsibilities
Hands on expertise in catheter manufacturing processes, process improvements, fixturing, and tooling needed to improve process yields, provide solutions to increase equipment capacity.
The planning and management of manufacturing engineering assignments including manufacturing process improvement, installation qualifications, specification revisions, Engineering Change Orders, identification of process requirements, risk analysis, and process documentation.
Lead and conduct Cost Improvement Projects.
Lead and train Kaizen teams,
Develop work flow; implement One-Piece Flow for Lean Manufacturing
Train assemblers, team leaders and supervisors;
Trouble shoot production quality and yield issues
Identify root causes and corrective actions for manufacturing issues.
Conduct and/or participate in developing Process Validation Protocols; then conduct and document Process Validations.
Participate in the overall engineering management system including regular meetings and discussions around project priorities & status updates.
Design and validate fixtures and tooling.
