Senior Engineer, Mechanical, MedTech Catapult

Company not disclosed

Singapore
Salary not specified
Posted
Full-time
Apply on LinkedIn

Job Description

MedTech Catapult is a national platform, hosted by the Agency for Science, Technology and Research, Singapore, that supports the productisation and commercialisation of high-value medical devices and life science instruments towards venture financing, market readiness and manufacturing. Role Description - Develop and engineer novel medical technology products from concept to pilot production. - Design, develop and test devices by building functional prototypes in a laboratory and test environment. - Production of high-quality engineering drawings and assembly specifications. - Develop feasibility and reliability testing plans, including the development and validation of accurate in-vitro and in-vivo models and methods. - Plan and perform verification and validation (V&V) activities and documentation to ensure compliance with requirements. - Support development of intellectual property portfolio in device design and process technology know-how. - Prepare and support product development and quality planning (project schedule, resources, budgets, etc.). - Work on design for manufacturing by designing and developing pilot manufacturing equipment and procedures whilst assessing feasibility of processes and support manufacturing with validation plans and time studies. - Collaborate with outside vendors on the design and sourcing of materials, components, and processing. - Prepare documentation to support quality system for design functions (concept document, risk analysis including FMEA, design input, design output, test results, drawings, etc.). - Complete activities according to project phase checklists. - Review document changes in manufacturing for impact on design intent. - Interact closely with engineers from other disciplines to achieve an optimized design within the stipulated project schedule. - Provision of technical input to help identify and mitigate project risks affecting project schedules and plans. - To support other activities for product engineering when required. Qualifications - Bachelor’s or Master’s degree in Mechanical Engineering or related fields. - Minimum 5 years of experience in the design and development of medical devices/life science instrumentation. - Proficiency in computer applications, including MS office, SolidWorks or alternative CAD software. - Prototyping and materials knowledge for medical devices - Experience with FDA 21 CFR Part 820 and ISO 13485 quality management and regulatory requirements. - Experience in the design of electromechanical motion systems, fluidics and optics is a plus - Experience in thermal management simulation and electromagnetic enclosure shielding design is a plus. - Experience in material selection and biocompatibility is a plus - Strength in problem-solving and decision-making - Highly motivated, attention to details and a sense of urgency - Highly organized, proactive, and effective in collaborating across cross-functional teams. - Demonstrate strong interpersonal skills and leadership skills

Similar jobs

Ready to apply?

Apply at the source, or let Jd help you prepare your application.

Apply on LinkedIn