Join us today and make a difference in people's lives!
Job title: PTS Development Engineer
The PTS Development Engineer position is to assume responsibility for the coordination and control of all aspects of the design process for medical devices manufactured at LivaNova in compliance with customer requirements, company policy, ISO 9001, the Australian Medical Device Regulations, and/or other relevant statutory and regulatory requirements. This includes working with sales, customers, suppliers and other internal stakeholders.
Duties and responsibilities:
Liaising with and supporting Sales, customers (cardiac surgeons and 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. Process all customer Product sample requests, complete designs and take part in sample Preparation in the cleanroom working closely with the allocated Production Sample builder, review design and set up. Develop, maintain and improve the PTS (Perfusion tubing System) designs for continued regulatory and customer compliance. Address all customer and internal design issues or queries updating corrective actions where appropriate. Support the implementation of set up drawings or similar to assist Production with the assembly of the designs Manage pack timing and work to improve pack timing methods with the upcoming implementation of automated timing process. 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 Identify opportunities for product cost improvement, design or revised packs to address customers’ requests and manufacturing requests in the same time Participate in training all staff in comprehending Product drawings. Support all projects addressing PTS Development improvements Develop, maintain and improve all PTS Development documentation. List and maintain all new and old product catalogue numbers on the system, including number allocation, drawing, costing and system updates. Processing and analysis of all reports relating to design. Increase knowledge inside the PTS Development department, Archive all hardcopies of documentation Preparation of Reprocessing documentation Interacting with Production personnel to validate processes and procedures for product development or assist with queries regarding product design or processes. Working with Quality for customer complaints, root cause analysis and initiate corrective actions. Liaise with quality to assist in sterilisation validation processes Participate in internal and external compliance audits. Familiarise and maintain knowledge of all Regulatory requirements, Technical files, Intended Use Sterilisation Parameters etc. Maintenance and cleanup of all Exact, Data Master Record and Mastercontrol databases as products are created and superseded. Complies to all company policies and procedures, including health and safely compliance. Complete any other tasks assigned to you by your manager.
Tools and technologies used in the role
Requirements for the role
Tertiary qualification in Engineering, Science or Drafting/Design (or equivalent technical experience)
Minimum 7 years’ experience medical devices or Pharmaceutical Manufacturing facility being exposed to regulatory requirements, with knowledge of Perfusion tubing Systems highly regarded
Customer Service Orientation
Experience working within a quality management system
Proficient with AutoCAD 2018
Good problem solving and analytical thinking skills
Knowledge of Microsoft Office products such as Word, Excel and PowerPoint.
Experience with Sterilisation is desirable.
This individual will possess a unique combination of clinical knowledge, device manufacturing experience and circuit design expertise in order to transfer the Perfusionist’s vision from the Operating Room to the production floor and back to Operating Room again.
Our commitment to Diversity & Inclusion:
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Background Checks at LivaNova:
Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check. This process is not currently valid in Germany.
Notice to third party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.