Pts Design Engineer

Purpose & Context                                                                

Being a world leader in Cardiovascular and a leading player in Neuromodulation, LivaNova (approx. 3000 employees worldwide) is committed to applying its wealth of knowledge and technological expertise, acquired through decades of research and development to create therapies - products and services - that deliver the highest level of quality.  Working with our organization is not just a career; it's the chance to make a difference in the lives of more than one million patients every year, in over 80 countries.

As a part of the LivaNova Family you commit to uphold our Mission, Value and Pillars to;

• Put the Patient First
• Meaningful Innovation
• Act with Agility
• Commitment to Quality and Integrity
• Collaborative Culture

Alongside this, your purpose is to successfully assemble Perfusion Tubing System (PTS) Packs to the highest quality and meeting regulatory compliance for the manufacture of medical devices in accordance with organization policies and procedures and Australian Medical Device regulations, ISO 9001 and other relevant statutory requirements - ensuring they are complete on time.

Duties and Responsibilities                                                    

• Develop, maintain, and improve the PTS (Perfusion tubing System) designs for continued regulatory and customer compliance.
• Follow Engineering Change Order process.
• New catalogue number allocation, drawing, costing, and updating system.
• Ensure new product designs and changes to existing products are biocompatible according to ISO 10993-1
• Manage pack timing and work to improve pack timing methods with the upcoming implementation of automated timing process.
• Process all customer Product sample requests and take part in sample Preparation in the cleanroom working closely with the allocated Production Sample builder, review design and set up.
• Working with Quality for customer complaints, root cause analysis and initiate corrective actions.
• Familiarise and maintain knowledge of all Regulatory requirements, Technical files, intended Use Sterilisation Parameters, Risk Management etc.
• Risk Management – update and review risk management files based on updated requirements. (FMEA). 
• List and maintain all new and old product catalogue numbers on the system.
• Address customer and internal design issues or queries often initiating corrective actions. 
• Maintenance and cleanup of all Exact, Data Master Record and Mastercontrol databases as products are created and superseded.
• New component requests, Component testing and Validation, review for compatibility in use and material specification creation on component approval and maintain specifications, work to improve current testing methods
• Interacting with Production personnel to validate processes and procedures for product development or assist with queries regarding product design or processes.
• Maintain and improve all Design Department documentation.
• Participate in internal and external compliance audits.
• Participate in training all staff in comprehending Product drawings.
• Liaising with and supporting Sales, customers (Perfusionists) on cardiovascular circuit design and technical design requirements and issues as required. Perform customers visits on site when required. Identify & implement policies for continuous improvement of systems and processes.
• Identify opportunities for product improvements, taking into consideration costs, customer and manufacturing needs.
• Support the implementation of set up drawings or similar to assist Production with the assembly of the designs
• Support all projects addressing manufacturing department improvements
•  Liaise with quality to assist in sterilisation validation processes
• Preparation of Reprocessing documentation 
• Complies to all company policies and procedures, including health and safely compliance.   

Behavioural Traits                                                                 

• Methodical
• Strong emphasis on attention to detail
• Good problem solving skills
• Good communication skills (both written and verbal)
• Work through challenges
• Respectful of others & Operate with Integrity
• Outcome Orientated Focus on achievement
• Dynamic and Forward facing,
• Rich in Knowledge of manufacturing processes
• Accountable for our actions,
• Act with a sense of urgency
• Ability to learn and adapt to changing business environments

Reporting

• Design Drawings

Authority to Act                                                                     

• Applicable LivaNova policies and procedures
• Corporate Guidelines

Skill and Knowledge                                                              

• Tertiary qualification in Engineering or Science is highly desirable (or similar technical background)
• Experience in medical devices or Phamaceutical Manufacturing, with knowledge of Perfusion tubing Systems is highly regarded 
• Advanced Microsoft Office skills such as PowerPoint, word and Excel
• Experience working with AutoCad
• Understanding of ISO 10993-1, ISO 13485 and TGA Regulations
• Sterilisation knowledge