The primary role of this position is the design or improvement, implementation, and validation including maintenance of the processes required to produce Saluda’s active implantable medical devices.
Accountabilities and Associated Responsibilities
-Responsible for the performing process validation activities, including tool validation;
-Responsible for ensuring processes continue to be capable of producing the required outputs with the required quality level;
-Responsible for addressing work instructions and ensuring they are of an appropriate standard.
-Identify Critical Process Parameters and design effective control systems;
-Train production operators and ensuring operators are able to consistently produce quality outputs;
-Ensure operator training records are up to date;
-Track and optimize yield and process capability;
-Contribution to risk documentation including pFMEAs;
-Ensure proper change management procedures are followed;
-Design and transfer of Tools/Jigs/Assembly aids;
-Responsible for ensuring all relevant tool records are up to date complete and accurate.
-At least 3 years’ experience in process design, development and validation preferably in a highly regulated industry;
-Very good written and verbal communication skills;
-Bachelor’s degree or higher in Manufacturing Engineering or equivalently relevant field;
-Strong problem-solving and leadership skills.
-Working knowledge of regulatory requirements;
-Experience in the Medical Device industry;
-Experience in the Neuromodulation industry;
-Experience in working within a controlled clean room environment.