Teva Senior Mechanical Engineer 

Croatia, Zagreb 

288081444

There are three product technology clusters within CPD Abbots Park, each broadly focused (although not exclusively) on a particular subset of injection devices:
• Cartridges & Pen Injectors
• Pre-filled Syringe & Safety Systems (PFS)
• Autoinjectors (AI)

As Senior Mechanical Engineer you will ensure that the products for which you are responsible are safe and effective through the application of best practice engineering, the application of Design Controls and Safety Risk Management and your knowledge of the relevant combination product regulations, directives, guidelines and standards. You will also use your experience of production processes and manufacturing technologies, such as plastic injection moulding, to prepare those designs for transfer into production. Your creativity, knowledge and experience will enable you to identify and to and resolve complex engineering problems. You will also contribute to the development and maintenance of departmental operating systems and processes and have the opportunity to influence departmental best practice.

• Supporting the engineering design and development of drug delivery devices at various stages of development, from research, through verification and validation, and into life-cycle management.
• Ensure that products for which you are responsible are:
  • Engineered to be reliable and robust, through the application of appropriate design, analysis and testing.
  • Verified by the provision of suitable objective evidence.
  • Documented in compliance with CPD’s Quality Management System.
• Lead or support Safety Risk Management activities
  • Including Hazards identification, analyzing and evaluating risk (by conducting design Failure Modes and Effects Analyses (FMEAs) and supporting the Manufacturing, Science & Technology (MS&T) function to conduct process of risk assessments).
• Lead or support technical design reviews to assess robustness and safety and documentation quality compliance.
• Lead or support investigations to identify root causes of device issues using established techniques, e.g. Fault Tree Analysis, Design of Experiments.
• Contribute to the continuous improvement of departmental processes, including supporting development of Standard Operating Procedures, guidelines and templates, introduction of new software tools etc.
• Some domestic and overseas travel may be required (e.g. to visit suppliers’ facilities, Teva manufacturing sites), approximately 10%.
  

• Graduate in Engineering, Scientific or other Technical discipline.
• Experience in the design, manufacture and life-cycle management of medical device or combination products from concept to commercialisation (preferred, or, as a minimum, expertise from another relevant industry).
• Operates with a high degree of independence on engineering tasks, with only limited support or guidance required.
• Training in Design Controls, medical device Safety Rrisk management Management and European Medical Device Directive/Regulations (preferred).
• Familiarity with statistical methods, for example for the determination of design input requirements, verification and validation testing, especially the derivation of test sample sizes proportionate to risk.
• Excellent 3D spatial awareness and visualisation of concepts, mechanisms and assemblies
• Knowledge of Solidworks 3D CAD (preferred).
• Analytical engineering assessment of mechanisms and systems, building understanding from a “first principles” basis.
• Can effectively cope with change, coping with risk and uncertainty while comfortably adapting to changing conditions.
• Good verbal and written communication including high quality engineering documentation.

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