Safety Engineer

04 Oct 2016
20 Oct 2016
Contract Type
To support the growth of the Elekta business and our constant innovation in patient care, the Global Engineering business is expanding its capacity and looking to bring on a number of people into several exciting new roles. Elekta is a medical device manufacturer that pioneers significant innovations and clinical solutions for treating cancer and brain disorders. Elekta provides highly complex systems comprising software and electro-mechanical devices that improve, prolong and save patient lives worldwide. Safety assessment is a key part of the development processes for Elekta's range of products which involve radiation, high voltages, moving machinery, and many interconnecting software devices. A changing regulatory landscape for medical devices is driving increased emphasis on both functional safety analysis and safety related usability assessment. Elekta are therefore seeking Safety Engineers to further strengthen our safety department. The Safety Engineer ensures that the Elekta safety process is applied effectively to the project. The Safety Engineer provides a co-ordinating and facilitating role to ensure safety tasks on the project are completed and that safety is central to all the teams' activities. 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. Successful applicants will either have experience in the medical devices field, or be able to bring experience of conducting risk assessment from other safety critical industries. You will be able to demonstrate excellent communication skills and the ability to negotiate and influence at different levels of the organisation. Qualifications Knowledge: Safety policy and principals, Safety Risk Management lifecycle process, hazard identfiication techniques including FMEA and FTA, Usability principles and procedures. Educational: No specific requirement, typically 1st degree in science or engineering; Experience: Applying Safety methods as part of a product development team in a safety critical industry. Creating risk assessments on hardware or software and at the system level; report writing; document reviews; design reviews Useful: Sector knowledge, knowledge of safety standards. Personal skills: excellent communication, including negotiating and influencing across different functions and seniority levels experience of documentation and report writing; analytical and logical; commitment to complete assignments and ability to work as part of a team; Able to use initiative, remain objective, escalate and seek advice as appropriate. Responsibilities Project work: Planning safety activities for a project in compliance with the Elekta safety process. Performing and facilitating safety analysis of concept designs in a multi-discipline group to influence early design decisions. Performing, facilitating and reviewing detailed design hazard analyses to identify and record hazards, causes, risk levels, and risk reduction methods. Preparation of a safety case that argues whether the risk from a product is acceptably low Released product assessment: Performing risk assessment on problems reported from the Customer Feedback Reporting process and making recommendations for appropriate action. Other: Monitoring changes in safety standards, and using knowledge of best practices to improve Elekta's safety engineering processes Delivering training to non-safety personnel on risk assessment processes and hazard identification techniques