Our client is an outstanding, innovative developer of a variety of medical devices. In response to the current Covid-19 crisis, they have been engaged to carry-out an important and exciting product development and manufacturing project. Additional staffing resources are required to assist, and due to the urgent and complex nature of this project, we are seeking applications from engineers with proven experience working in a medical device manufacturing environment.
Along with proven medical device engineering experience, we also (ideally) require someone that can start ASAP.
Duties include (but are not limited to):
- Developing and establishing manufacturing processes - Take technical ownership for designs, design reviews, and process flow charts
- Provide manufacturing support - Carry out continuous improvement activities on existing lines, assist manufacturing teams with ensuring product quality and achieving delivery targets
- Work with Production Operators to provide solutions technical manufacturing issues
- Carry out NCRs, RCAs, CAPAs and feasibility risk assessments
- Preparing technical documentation including SOPs, BOMs and PFMEAs
- Supplier management - Liaising with suppliers, assessment and qualification, management of issues, supplier performance improvement, supplier development
- Ensure that all manufacturing activities are compliant to ISO 13485 QMS
The Successful Candidate will possess:
- Approximately 5 - 8 years of experience as an engineer in a medical device environment
- Tertiary engineering qualification in engineering - Mechanical, Electronics or related
- Strong experience with lean manufacturing techniques and continuous improvement
- Strong competency with working in an environment regulated by ISO 13485, ISO 9001, GMP and FDA standards
- Excellent team player abilities and great interpersonal skills
- Excellent communication skills - Both written and verbal
Our client boasts an amazing work environment - One where diversity, innovation, openness and collaboration are all strong parts of their culture.
Applications in Word Format will only be considered (No PDF Documents please).
Questions can be directed to Leah Creswick at Fuse Recruitment on 0478 193 170.