The primary role of this position is the design, implementation, and validation of the processes required to produce Saluda’s active implantable medical devices.
Accountabilities and Associated Responsibilities
– Responsible for the planning and implementation of process validation activities, including tool validation;
– Responsible for ensuring processes are capable of producing the required outputs with the required quality level;
– Responsible for maintaining work instructions and ensuring they are of an appropriate standard.
– Identify Critical Process Parameters and design effective control systems;
– Responsible for training operators and ensuring operators are able to produce quality outputs;
– Ensure operator training records are up to date;
– Track and optimize yield and process capability;
– Facilitate daily stand-up meetings and manage actions;
– Contribution to risk documentation including pFMEAs;
– Ensure proper management of changes to processes;
– Ownership of Tools/Jigs/Assembly aids;
– Tracking of tool instances and ensure calibration and maintenance is performed and up to date;
– Responsible for ensuring all relevant tool records are up to date complete and accurate.
– At least 5 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.