Risk Management Engineer - Medical Devices

AKKA is the European leader in engineering consulting and R&D services in the mobility segment. As an innovation accelerator for its clients, AKKA supports leading industry players in the automotive, aerospace, rail and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies (AI, ADAS, IoT, Big Data, robotics, embedded computing, machine learning, etc.). Founded in 1984, AKKA has a strong entrepreneurial culture and is pursuing its fast-paced growth and international development in line with its CLEAR 2022 strategic plan. With 21,000 employees, who are passionate about technology and dedicated to advancing the future of industry, the Group recorded revenues of €1.5 billion in 2018. With a view to strengthening our team, we are looking for a: Risk Management Engineer - medical devices The risk management engineer will join the R&D team and work in close cooperation with the project leader, performing risk analyses and related tasks for disposable medical devices. Profile: The risk management Engineer will be responsible for the following tasks: Management of Design History File documentation to ensure the traceability - Design Control Management: Design Plan, Product requirement specification, Design Review, Design Change, Post - Production Change, V&V test definition Verification & Validation Risk Management (FMEA, FTA): Definition of the Hazardous situations, assessment of the residual risks and definition of the risk control measures, Risk/Benefit analysis - ISO 14971 Usability Assessment (Heuristic analysis, Formative/Summative evaluation test, User Interface Specification, Usability risk assessment). Preparation of the usability procedure with the related form, template - IEC 62366 Skills: MSC in Biomedical Engineering or equivalent background. Knowledge of relevant international standards: ISO 13485 ISO 14971 ISO 62366 Previous experience in risk analyses/risk management is required. Good command of written and spoken english. Offer Permanent Employed. Place of Work Mirandola (MO) ...