Company 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
