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)
Skills Required
- Graduate-level BEng or BSc in Mechanical Engineering, Biomedical Engineering, Product Design, or a relevant subject, or equivalent education or experience
- Understanding of the orthopedic field or other highly regulated environments
- Ability to use CAD, FEA, and PLM software for design work
- High level of computer literacy
- Ability to collaborate with colleagues, customers, suppliers, manufacturing, quality, and regulatory teams
- Ability to manage multiple tasks, organize work, and track completion
- Ability to make evidence-based decisions and solve design problems
- Ability to work effectively in a fast-paced, high-pressure environment
- Ability to lead aspects of design projects and CAPA projects
- Knowledge of design controls, risk management, ISO 13485, GMP, or FDA 21 CFR Part 820
- Ability to present project information to customers and stakeholders
What We Do
As a leader in orthopaedic innovation, Corin has pioneered a number of landmark developments since its foundation and is proud to have been able to improve the quality of life of thousands of patients around the world through these groundbreaking products. The company’s talented and dedicated teams share a common commitment to deliver quality orthopaedic products and services to patients, surgeons and healthcare providers which exceed expectations and positively impact lives. With an increasingly active and demanding patient population, the need to provide state of the art conservative treatment pathways, in addition to more traditional interventions, has never been more important. Corin’s product portfolio is designed to provide each patient with the optimal solution, utilising some of the most advanced technologies available in the world to enhance implant longevity and performance.
