Job Summary

Roles & 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