Senior Safety Engineer : Elekta

Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

DESCRIPTION -

The Safety Engineer ensures that the Elekta safety process is applied effectively to a project release. While the Safety
Engineer shares responsibility for safety with the project team, the Safety Engineer’s expertise on safety related matters is expected to
take the lead in the group producing safe products.
Principal and senior grades are expected to deliver the responsibilities at a higher level, provide greater influence on product
specification and global strategies on safety engineering.

RESPONSIBILITIES -

The Safety Engineer has the following responsibilities:
Project work:
The following activities are delivered through active participation in a shared service Agile team:

• Planning safety activities appropriate to the size of the project/release and commensurate with the risk from the intended use and characteristics of the product.
• Ensure that the planned activities are applied effectively throughout the project.
• Ensure suitable techniques are applied to analyse design and design changes to identify hazards, causes of hazards and estimate
• their risk and record the evidence of this analysis
• Ensure appropriate risk control measures are applied to reduce the risk from hazards to an acceptable level.
• Review the safety activities for completeness and effectiveness and prepare a safety case on behalf of the project team that argues activities for the project have sufficient progress and risk is acceptable to release the product. Where the risk is not accepted by the project team, provide the Project Steering Group with the information necessary to make an informed decision regarding release.
• Identify and package work for delivery through Global Engineering, sub-contract or outsource resource

Post Production Assessment:

• Perform risk assessment on problems on released products reported through the Customer Lifecycle Management (CLM) Process

Process improvement:

• Use expertise to support process improvement activities to respond to changes in standards, and improve the efficiency of the safety assessment process in line with scaled agile framework

AUTHORITIES –

•  Creation and review of risk assessments resulting from CLM Reports
•  Creation of Safety Risk Management Plans and Reports
•  Addition to and review of Product Hazard Analysis in the Hazard database

RELEVANT KNOWLEDGE, SKILLS AND COMPETENCIES

Knowledge:

• Risk Management policy and principals;
•  Risk Management processes;
•  Safety standards, preferably including ISO 14971, IEC 61508; or IEC 61511;
•  Sector specific knowledge is preferable, including IEC 60601.
•  Usability principles and procedures; desirable

Educational:

• No specific requirement, typically good 1st degree in science or engineering.

Experience:

Applying Hazard Identification and risk assessment methods as part of a product or process plant development process;

•  Creating risk assessments on systems (preferably both software and hardware);
•  Report writing;
•  Document reviews;
•  Design reviews.

Personal skills:

•  Good communication, in particular through documentation and report writing;
•  Analytical and logical;
•  Commitment to complete assignments;
•  Ability to work as part of a team;
•  Able to use initiative, remain objective, escalate and seek advice as apprprate.