AUS- Design Engineer in Sydney

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).

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