Cook Medical is a global medical device manufacturer, committed to improving medical care worldwide.
We are seeking the services of dedicated Post Market Engineer to join our team at our Australian head office located at Eight Mile Plains.
About this role:
Reporting to the Team Leader - Post Market Engineering, this role is responsible for leading and/or assisting in post-market design activities for current products, and corrective and preventive actions across the company, whilst managing engineering driven projects/programs.
- Lead and/or assist in post-market activities for current products including:
- Maintaining the design of the medical devices to ensure continued compliance with current state-of-the-art. This can include but is not limited to design changes, testing and risk management activities.
- Preparing documentation to support submissions and responses to regulatory authorities
- Lead Corrective and Preventive Actions (CAPAs)
- Manage engineering driven projects or programs including working with external contractors on post-market projects where applicable
- Support evaluation of design related supplier changes
- Interact effectively and professionally throughout various levels of the global organization and with external contractors
- Ensure personal compliance with COOK values, quality system procedures, policies and relevant medical device standards and regulations
- Conduct education/training events and activities for the R&D team
- Tertiary Engineering Qualifications essential
- Knowledge and experience in the application of Medical Device Design Controls desirable
- Knowledge and experience in the application of Risk Management Techniques desirable
- Knowledge and experience in the application of Corrective and Preventive Action processes desirable
- Documentation in accordance with strict quality management systems is an essential part of this role so the applicant must have good technical writing skills and attention for detail
- Experience working across multiple projects and disciplines with good time management skills desirable
- Experience in a Medical manufacturing environment desirable
- Demonstrated strong project management skills desirable
- Intermediate statistical data analysis skills and experience desirable
Please note only applicants that have full working rights within Australia are eligible to apply. Please apply with your CV and a cover letter outlining how you meet the requirements of the role. Shortlisting may commence immediately after advertisement posted.
Cook as an employer:
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a private corporation. The Australian Head Quarters is located in the Brisbane Technology Park, Eight Mile Plains, Queensland. Our manufacturing operation is steadily growing and manufacturing more complex devices for our global markets.
Cook Medical has over 10,000 employees worldwide, operates directly in 39 countries and delivers products to 135 countries around the world. Cook Medical produces over 7,000 different products for the global market.
The future of medical care has never been more exciting.
If you would like to know more about Cook Medical please visit http://www.cookmedical.com
If you are an experienced Engineer wishing to join a highly regarded company and possess all the requirements above, please apply via the link below: