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Systems Engineer (Medical)

Keywords / Skills : testing, Risk Analysis, Basic

5 - 8 years
Posted: 2018-10-13

Nationality
Singapore
Industry
Recruitment/Staffing/RPO
Function
IT
Role
Systems Engineer
Posted On
13th Oct 2018
Job Ref code
8625
Job Description
My client is a global player in the development and manufacturing of innovative medical devices and life science products catering towards a wide range of industries and as part of a directive to expand innovation across APAC, an experienced Systems Specialist is required who would be responsible for the vital role in defining and developing future products and their life cycle. Basic Responsibilities: Act as Lead for Design FMEA and ensure cautions are taken against potential risk Application of DFSS principles and tools to assess/select alternatives and to improve the quality of products under development Decompose system requirements and allocates to subsystems. Lead/oversee the development of system requirement specifications by working jointly with the Subsystem Technical Leads to ensure that the content is developed by the appropriate subject matter experts. Identify technical risks and makes recommendations for risk response strategies and fallback plans. Participate in or lead intra-function teams of engineering, verification, and validation staff to achieve systems design and test goals in addition to participating in or leading cross-functional technical teams to drive and coordinate overall system development Contributes as a team member on development projects carrying out assigned responsibilities in a timely, diligent, safe, and professional manner. May act as a project leader As a contributor to the Risk File, develop risk management deliverables in accordance with the ISO 14971 & Risk Management Plan to confirm a high degree of product safety. Lead the Usability Engineering activities to ensure the application of human factor in the development of device and demonstrate compliance to IEC 62366 and FDA Identify gaps in design proposals, technical capabilities / techniques, and supports the development of strategies to overcome them through DFM & DFS practices. Conduct technical design reviews at system or subsystem levels in projects. Interface with subsystems and other project stakeholders to ensure that the system objectives are balanced with overall project objectives Work with engineering disciplines to translate User Needs into System/Subsystem Requirements Specifications to ensure product achieves performance, functionality and reliability Conduct technical design reviews at system or subsystem levels in projects and complete and maintain the system Risk Analysis documents Ensure the system reliability is achieved during design through reliability plans and testing. Requirements: Preferably a Masters in Electrical/Electronic/Mechatronics or Systems Engineering with 5-8 years’ experience in new product development of a complex integrated system (life science, medical or consumer product portfolio DFSS, Requirement Analysis, Linear Trap Technology, Knowledge Engineering or Systems Engineering experience preferred and a familiarity with ISO 13485 is an advantage Experience in a Phase-Gate development process and design production equivalent rapid prototypes Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).



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