Responsible for Design for Manufacturability (DFM) with the Client.
Responsible for Device Master Record (DMR) development.
Responsible for the process flow development including value stream mapping, process and product characteristics, and CTQ flow through.
Supports pFEMA development and team discussions along with managing the risk mitigation activities and testing.
Supports Control Plan (CP) development including inspection methodology, prevention controls, detection controls, reaction plans, inspection frequency rationale, and ongoing monitoring.
Leads engineering test protocol development and reporting for process characterization and process testing.
Designs tools and fixtures with CAD/CAM systems.
Develops manufacturing processes for New Product Introduction and writes applicable work instructions.
Bachelor’s Degree in Mechanical Engineering
Lean process and product development is ideal
5+ of years of experience with tight tolerance methods in machining and measurement system applications, blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations
Windows-based computer knowledge
Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic understanding of the human anatomy preferred
Knowledge of various metal and polymer materials as well as testing specifications preferred
Program CNC machinery with MasterCam or Unigraphics
Continuous improvement and process improvement skills
CAD / CAM