Senior Systems Engineer, Medical Devices
|Job Title:||Senior Systems Engineer, Medical Devices|
|Contact Name:||Phua Shyan-Hwei|
|Job Published:||July 24, 2018 13:46|
This is an engineering leadership role, and the successful candidate will be responsible for implementing and maintaining systems engineering processes which support the successful development of medical devices. You will function as a technical facilitator with technical skill and domain knowledge to identify technical risk, challenge design decisions and bridge the gap between functional elements of the product development process.
Some of your key responsibilities include
- Lead key work-stream activities with a robust approach to the design, creation, and operation of systems of new product development facility including supporting required quality system obtainment.
- To lead and manage identification and quantification of system goals, creation of alternative system design concepts, performance of design trades, selection and implementation of the best design, verification that the design is properly built and integrated, and post-implementation assessment.
- Lead the design and application of the whole solution as distinct from the parts
- Manages design process and creates or acts as a consultant in the preparation of documents which form the design history file for the medical device
- To monitor budget, resource and progress against key milestones
- To ensure that the Technical content of a project plan reflects the customer needs specification, is comprehensive, credible, accurate and represents a challenging but achievable delivery target.
- Establish and manage key interfaces with third party suppliers, particularly but not exclusively key manufacturing sites, to enable rapid implementation of New Products.
- Ensure at the onset and throughout the project that the responsibility for the identification, generation of equipment, and associated funding is clear and that implementation and transfer is efficient and effective.
- To create technical documentation as required by the team, ensuring that the project file is suitable for relevant notified bodies, and to present the project at such audits.
- Work with Project Management to prepare and update Project Schedules and acts as a leader or co-leader for programs as developed per the Strategic Product Definition Process.
- Works with the in-house legal department, outside legal consultants, and Government Patent Officials, as required, on patent searches, patent infringements, and patent applications.
Degree qualified, ideally in Systems Engineering, you will have at least 10 years of experience in a regulated industry, with recent experience in systems engineering including human factors engineering, design control, risk management and quality management systems. You will have knowledge/exposure to FDA requirements or Design Control for Medical Devices (CE MDD and MDR) and possess a strong understanding of the regulatory needs relating to medical device. You possess the ability to plan and execute technical and engineering requirements for medical device product development through consideration of the whole system and user interaction
Singapore Employment Agency Licence No: 16S8069
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