Failure Analysis Engineer

Summary about this job

Detail information about job Failure Analysis Engineer. Terms and conditions vacancy

• Opportunity to join a fast growing Australian medical device start-up
• Be a part of our innovation & technology
• Great work culture and supportive team

Saluda Medical is a medical device company whose aim is to develop advanced neuromodulation systems for the next generation of implantable neurostimulation devices. The primary role of this position is to conduct timely failure investigations to root cause conclusion for input into design, development and manufacturing improvement activities.

About the role

• Develop and conduct standard failure analysis practices for Saluda Medical.
• Ensure appropriate testing methodologies and processes are used and validated, develop novel methodologies when needed.
• Establish reliability reporting for Saluda Medicals product lines.
• Ensure documentation complies to the Quality Management System.
• Manage tools and equipment for conducting failure analysis in the Quality Management System to ensure compliance to applicable regulations for maintenance, calibration, traceability and process validation (including test method validation).
• Define, document, plan and conduct failure analysis activities for each device type including the establishment of failure codes to allow trending.
• Assist in the investigation of any manufacturing and design activities.
• Write technical protocol and reports and work with internal SMEs to develop design and development documents and presentations when appropriate.
• Develop and implement investigation cross-functional review teams to review and approve final reports.
• Escalate as appropriate to CAPA team for example where quality issues are identified or data may be ambiguous.
• Provide the appropriate level of information to allow timely Post Market Surveillance activities such as Medical Device Reporting (MDR) and Vigilance Reporting for device related issues.
• Provide input to Post Market Surveillance activities for trending and data analysis.
• Provide input to allow update of risk management files.
• Provide succinct summaries for complaint files and customer communication (when needed).
• Continually assess the end to end process to ensure efficient, effective, predictable and timely device analysis and provide metrics for Management Review.
• Performs duties in compliance with Saluda Medical's Management System comprising the company policies regarding the Quality Management System, health, safety and environmental compliance.

Essential Requirements:

• A Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering or related discipline.
• Proven self starter/able to take initiative
• Strong investigative/problem-solving/change management skills.
• Experience in failure analysis or material/product testing.
• Commitment to engineering development in a QA controlled environment.
• Excellent written and verbal communication skills. Ability to produce reports & presentations to a professional standard. .Experience in medical device, electronics, semi-conductor, automotive or aeronautical industry.
• Ability to work in a team and with minimum supervision.

Desirable Requirements:

• Working knowledge of medical device regulatory requirements
• Experience in medical device, electronics, semi-conductor, automotive or aeronautical industry.
• Experience in the Neuromodulation industry.

If you would like to be part of our team developing the world's next generation of implantable device technology, please apply online now.