Principal Engineer
7 months ago
The MedTech Catapult has a dedicated objective of curating and accelerating the development of high potential MedTech projects through an in-house product engineering unit. This productization unit is responsible for supporting the development of technologies through the medical device development cycle to produce full-fledged hardware product systems. The Principal Engineer will report to Programme Director.
Job Responsibilities:
Oversee the technical engineering team and work with cross functional team on the entire implementation relating to hardware, connected devices and related technologies for multiple projects in parallel. Guide and lead the development of systems architecture, requirements, specifications and verification reports, in creating hardware product systems that are developed in the productization unit Manage feasibility study for each phase on conceptual design for new products and product architecture from conceptualisation to completion Ensure product functions meet user expectations, technical requirements and fulfilling budget and quality specifications Oversee the analytical studies, verification and validation of the products Ensure compliance with the appropriate quality management system and regulatory specifications, and proper document control and communication with internal and external stakeholders Providing guidance, mentorship and direction to all engineers and stakeholders on product development Guide and oversee the development of system component requirements, interfaces, and specifications necessary to maintain the consistency and integrity of the architectures. Provision of technical input to help identify and solve project risks affecting project schedules and plans Review and approve documentations for QMS, approve risk analysis, risk management, Verification and Validation procedures. Performs hands-on system integration testing and troubleshooting of technical issues. Performs system level verification against requirements. Creates test plans, procedures and reports, performs and analyzes system set up, and conducts verification and validation activities. Identify and implement product design changes as required for individual products in accordance with internal and external stakeholders. Interface with external parties (design houses) to communicate product requirements, and subsequent knowledge transfer to build internal capabilityRequirements:
Masters in System Engineering, Electro-mechanical or related discipline > 15 years experience in medical devices (e.g. hardware, connected devices) managing product design and development, with hands-on experience in system architecture and integration of mechatronic and software systems Experience in Systems Engineering as related to stakeholder needs definition, creation of use case workflows, requirements definition and decomposition, functional architecture, and system design. Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports Outstanding communication and presentation skills (written and verbal) to all levels of an organization. Strong track record of technical leadership and working in cross-functional teams. Lead and coordinate with remote development teams Ability to work on multiple projects simultaneously Enjoy working in a small team, start-up environment-
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