Asst Manager - R&D Governance (Requirements Management)

• Conduct fundamental or studies which requires knowledge of a number of disciplines solve problems by sustaining, improving and generating new design development procedures, processes, systems, components and products :
• a) Standards/ tools/ methods
• Scope covering but not limited to Applied standards and monitoring; Review, analyze & reporting of new/ amendments in standards; Establish and monitoring of SOPs; System/ Tools for project management, research & development activities.
• b) Requirements Engineering and Process Assurance
• To evaluate and monitor development procedure/ SOP/ documentation/ specification/ records and to ensure they are in compliance with daily practice/operation of the development process. Support the development SOP and procedural documentation creation from the Ideation Phase until the Production Start-up Phase. Scope covering but not limited to REACH requirements, biological substances, regulatory affairs compliance; Support internal & external audit; Initiate and monitoring of periodic reviews for Development Process/Documentation; To propose and to implement Corrective Action needed to align the compliance of development practice and documentation.
• c) Risk management and usability engineering
• Scope covering but not limited to Risk Management and Usability Engineering/ Human Factors Engineering; Implement risk management and product risk analysis.
• Plan, design, and conduct complex projects using existing or new methods and theories to solve problems; and improve, or generate new, products, components, equipment, systems, and processes.
• Manage all aspects of an R&D project, from start to finish, so that it is completed on time and within budget.
• For more senior position, manage all aspects of a large scale, complex, or significant R&D project, from start to finish, so that it is completed on time and within budget.
• Design, communicate, and implement an operational plan for completing the R&D project; monitor progress and performance against the project plan; take action to resolve operational problems and minimise delays.
• Identify, develop, and gather the resources necessary to complete the R&D project.
• This may include preparing complex engineering standards, designs and work specifications; developing project schedules, budgets and forecasts; and selecting materials, equipment, project staff, and external contractors.
• Estimate the costs, resources, and time required to complete an R&D project and monitor activities, allocate resources and assign tasks to ensure these targets are met.
• Activities may include devising methods, calculating and analysing results and preparing detailed reports with recommendations and conclusions.
• Estimate the costs, resources, and time required to conduct one or more research projects and monitor the performance of these projects to ensure targets are met.
• Develop and maintain technical expertise on the scope mentioned above.
• Coach and mentor less experienced staffs; check the quality of their work and help them resolve problems.

• Bachelor's Degree with at least 3 years of working experience and experience in requirements management.
• Capability of structuring technical requirement system, including establishing requirement hierarchy and traceability system. Good understanding of requirement plan, input, output, analysis, verification & validation, and monitoring.
• To collect, break-down, categorize, define and review business as well as technique requirements. Be able to translate stakeholder needs and user needs into engineering language thereafter to functional and non-functional requirements.
• Implementing internal requirements and quality management SOP. Supervise the requirement engineering activities to ensure the process and deliverables are within the governance of the corresponding SOPs and standards.
• Basic knowledge of medical device development and quality management. Good sense of aligning high-level needs with engineering capability and capacity.
• Outstanding written skills in the English language. Good communication and persuasive skills.
• Experience of managing technique requirement especially in mechanical and electronic related disciplines. Traceble records of success requirement implementation in commercial products.
• Support internal & external audit; Initiate and monitoring of periodic reviews for Development Process/Documentation.

• Communicate effectively
• Be determined to achieve
• Be accountable

B. Braun