Key Responsibilities- Conducting internal process improvements for manufacturing- Managing multiple client projects for development of packaging solutions and manufacturing processes - Project lead for the development of an orthopaedic fracture fixation kit to be included in the ARTG- Managing the conformity assessment procedure with the TGA- Business development and client relationship management

Key responsibilities: - Developing new SOPs with GMP for the manufacturing of a Class IIb medical device- Performing low volume on demand production- Production process optimisation - Procurement of raw materials from suppliers - Conducting risk analysis to plan and implement controls to minimise critical risks - Management of key contractors and suppliers - Management of logistics and customer communications - Design and development of production jigs and methods

Key Responsibilities:- Design and development of a new Class IIb implantable vascular medical device- Prototyping using SolidEdge (CAD)- Design and development of V&V testing jigs - Drafting and authoring V&V protocols - Executing V&V activities by conducting physical tests and computational analyses- Performing risk management activities according to ISO 14971 - Creating training material for clinical users

Key Responsibilities:- Conducting a meta-analyses for an FDA submission - Extrapolating data and trends from clinical papers

Key Responsibilities: - Assisting with BSI external audits- Assisting QA/RA manager in conducting internal audits- Keeping raw material and stock counts up to date- Implementation of ISO13485- Performing gap analysis of ISO and EN standards- Assisting Project Manager with V&V testing - Assisting in manufacturing