RM - Risk Management Engineer

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland, SHL has sites in Sweden, Taiwan, and the Unites States. 【Job Overview】 我們正在尋找撰寫風險管理檔案(RMF)的人員，你會頻繁的與客戶和內部設計及研發單位溝通合作，運用工程及法規的知識，以提供符合標準的RMF。 The role requires application of regulatory and engineering knowledge to deliver Risk Management Files (RMF) for the device designed and manufactured by SHL Medical. The candidate will work with customers and internal stakeholders such as Design and Regulatory Affairs (RA) team to outline SHL Medical’s risk management scope and deliver the RMF in compliance with but not limited to ISO 13485, ISO 14971, ISO 11608. 【Main Responsibilities】 • Participate in project intake activities to understand and assess feasibility of project proposals from risk management perspective. • Communicate and work together with customers and their representatives (clinical experts) to request and review Medical Harm List (MHL) that meets SHL requirements for intended device. • Initiate Risk Management Plan (RMP) and Hazard Identification Checklist (HIC) and align the overall risk management deliverables with internal stakeholders and customer. • Review D-FMEA and P-FMEA from design and risk assessment lead for content accuracy and the risk control measures applied for overall risk acceptance. • Attend relevant project meetings to ensure all information required to develop, update, and maintain risk management documents for related projects are captured and utilized effectively. • Participate in relevant product lifecycle management activities to provide/collect information and ensure RMF are updated periodically. Changes to RMF may be initiated by but not limited to change control, audits, design changes, regulatory requirements and customer request. • Participate in internal and external regulatory audits and inspections, including third party audits of product risk management and relevant design history files. • Ensure periodic review of post market data with supervisor and RA personnel to update device risk management file as needed. • Cascade any information from Risk Management File updates to risk assessment and project team to ensure concise communication and effective implementation of changes. • Where needed, participate and contribute on end-to-end device risk management process in SHL Risk Management improvement activities and gap remediations. • Escalate potential issues and changes that may impact device risk management files to related team members and participate in the recovery plans to ensure business risk and compliance risk are handled in timely manner. • Maintain periodic communication with customers to ensure engagement and information exchange between SHL and customer to maintain effectiveness and compliance of device RMFs. • Remain updated proactively with regulatory changes and compliance changes and escalate for discussion with Risk Manager to assess impact and changes required to risk management process and device RMFs. 【Skills and Qualification】 • Masters in Life Science Engineering discipline with 2 years of work experience (or) Degree with 5 years of work experience. Exposure to medical device, pharmaceutical or biotechnology industry is added advantage. • Trained on Quality System Regulation, Risk Management or Design Control courses. • Demonstrated and applied a broad knowledge in quality management assignments and risk management approaches. • Good communication and interpersonal skills and demonstrate ability to participate in inter-departmental projects and resolve quality-related issues in a timely and effective manner.