Assistant Manager - R&D Governance (Requirements Management) - Growth-Minded Organization

• Conduct fundamental or studies which require knowledge of a number of disciplines to 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 minimize 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 analyzing 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 staff; check the quality of their work and help them resolve problems.

Requirements:

• Bachelor's Degree with experience of managing technique requirements especially in mechanical and electronic related disciplines.
• 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.
• Proficient in spoken and written in English and good in persuasive skills.