Senior Process Engineer

Sydney
Posted 2 weeks ago

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.

Essential Requirements: 

– 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.

Desirable Requirements:-

– Working knowledge of regulatory requirements;

– Experience in the Medical Device industry;

– Experience in the Neuromodulation industry.

 

 

Job Features

Job CategoryManufacturing

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