Lead, Product Engineering, Medtech Catapult

Job Summary Roles & Responsibilities MedTech Catapult is a national initiative for accelerating the development of high-value 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 Lead, Product Engineering. Responsibilities Lead design teams through full product development from conceptualization to early product production. Oversee the systems engineering plan 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 definition of system requirements, architecture, and interfaces to meet product requirements, risk analysis and industry standards, focusing on novel MedTech product systems 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 Support development of intellectual property portfolio in device design and process technology know-how. Providing guidance, mentorship and direction to all engineers and stakeholders on product development 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. Perform hands-on system integration testing and troubleshooting of technical issues. Perform system level verification against requirements. Create 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 capability Requirements Masters in System Engineering, Electo-mechanical or related engineering discipline >15 years experience in medical devices/life science instruments (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 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 The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.