Responsibilities Work within multi-disciplinary teams improving existing designs. Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions. Analyze manufacturing line from a risk perspective (p FMEA) to incorporate and validate critical tests used in manufacturing. Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ). Support Validations(IQ, OQ, PQ) Refinement of mechanical components and assemblies, with careful consideration for drivetrain components, safety mechanisms and failure contingencies. Machined component refinement including considerations for assembly, reliability, cost, and manufacturability. Authorship of design documentation for a regulatory controlled environment. Identify and implement continuous improvement projects with respect to first pass yield, cycle time ...