The posting
Design Engineer Corin is seeking an Design Engineer (PDE) to join our R&D team based at our Pymble, Australia office on a Hybrid (3 days a week) contract. As a Design Engineer, you will design medical hip and knee implants and instrumentation. The ideal Design Engineer will have/be: • A graduate level BEng or BSc in a relevant subject such as Mechanical Engineering, Biomedical Engineering, or Product Design or demonstrate a similar level of education or experience. • Able to understand the orthopedic field or other highly regulated environments • Able to build positive collaborations with colleagues, customers, and suppliers.• A high level of computer literacy • Well organized, able to manage its own time effectively and track multiple tasks at various levels of completion • The ability to make informed decisions based on available evidence and expertise • The ability to work at a fast pace in a high-pressure environment • A high level of accountability and ownership for own work, collaboration with others and projects • Self-starter attitude The key responsibilities of the Design Engineer are:• Design medical and mechanical devices, preferably orthopedic implants and associated instrumentation; ability to generate concept and detail design, using any appropriate method and dedicated CAD, FEA, and PLM software; take an active part in brainstorming and problem-solving as required • Generate full design package to facilitate design transfer to production in collaboration with Production and Quality Engineering function; this includes support / creating/filing/maintaining process and inspection sheets and any other design/manufacturing related documentation together with manufacturing drawings as required. • Produce and maintain design control, risk management documentation, and technical reports according to Corin's internal procedures and the required quality standard • Support Bioengineers providing biomechanical expertise• Liaise with Manufacturing, Production Engineering, Quality, and Regulatory teams internally to ensure the effective introduction of new devices and compliance with the regulation. • Interact with internal and external stakeholders in a professional manner including delivery of presentations where required • Demonstrate drive and motivation to become the key resource for the other team members supporting other team members effectively • Manage design; problem problem-solving ability by completing route cause and liaising with appropriate stakeholders to implement actions promptly • Ability to lead and manage key aspects of design projects as part of project core teams; ability to lead key aspects of and take part to CAPA projects •Contribute to the maintenance and base business activities of existing implant and instrument product systems in compliance with standard operating procedures and best practices. • Generate new design ideas and think outside the box • Present to customers about key aspects of projects • Carrying out work safely, efficiently, and diligently and complying with health and safety policies and procedures.Adhere to Corin’s Standard Operating Procedures (SOPs) • Adhere to the quality management system (Q-Pulse) and Quality Standards (IS013485 QMS and Good Manufacturing Practice (GMP) FDA21 CFR Part 820)
