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:
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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
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Manage feasibility study for each phase on conceptual design for new products and product architecture from conceptualisation to completion
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Ensure product functions meet user expectations, technical requirements and fulfilling budget and quality specifications
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Oversee the analytical studies, verification and validation of the products
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Providing guidance, mentorship and direction to all engineers and stakeholders on product development
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Guide and oversee the development of system component requirements, interfaces, and specifications necessary to maintain the consistency and integrity of the architectures.
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Provision of technical input to help identify and solve project risks affecting project schedules and plans
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Review and approve documentations for QMS, approve risk analysis, risk management, Verification and Validation procedures.
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Performs hands-on system integration testing and troubleshooting of technical issues.
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Performs system level verification against requirements. Creates test plans, procedures and reports, performs and analyzes system set up, and conducts verification and validation activities.
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Identify and implement product design changes as required for individual products in accordance with internal and external stakeholders.
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Interface with external parties (design houses) to communicate product requirements, and subsequent knowledge transfer to build internal capability
Requirements:
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Masters in System Engineering, Electro-mechanical or related discipline
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>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
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Experience in Systems Engineering as related to stakeholder needs definition, creation of use case workflows, requirements definition and decomposition, functional architecture, and system design.
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Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports
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Strong track record of technical leadership and working in cross-functional teams.
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Lead and coordinate with remote development teams
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Ability to work on multiple projects simultaneously
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Enjoy working in a small team, start-up environment
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