You're an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Responsibilities :
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 :-
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
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.
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.
Requirements :
Bachelor of Science/Engineering, preferably Quality Engineering, Risk Management, Medical Technology or equivalent.
Preferable someone with 1-2 years of experience in the related field.
Ensure methodological compliance for Risk & Usability Methods within Medical Device Development & Lifecycle-Management.
Preferable knowledge of ISO 14971:2019, IEC 62366-1:2020 and FDA Guideline for Human Factors 2016, and medical device regulations in an international environment. (MDR 2017, FDA CFR 820.30)
Knowledge in usability test moderation acc. to IEC 62366-1 and FDA Human Factors Guideline preferred, but not mandatory.
Fresh Graduates with CGPA3.5 are welcome to apply.
What We Offer
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.
Contact: B. Braun Medical Ind. Sdn. Bhd. | Sheryn | 04-632 4522
