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.  

Job Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Support early clinical feasibility studies and testing of functional prototype in hospital environment.
• Design, develop and test devices by building functional prototypes in a laboratory and test environment.
• Develop ISO 13485 compliant technical documentation for life science instrumentation
• 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.)
• Manage and assist with verification and validation activities and documentation
• Collaborate with outside vendors on the design and sourcing of materials, components, and processing.
• Support and prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, 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.

Requirements

• Degree in Engineering or science related fields.
• At least 3 years of experience in design & development of life science instruments/medical devices (e.g. hardware, connected devices)
• Computer skills including MS office, SolidWorks or alternative CAD program
• Prototyping and materials knowledge for medical devices
• Experience with FDA CFR 820 and ISO 13485 regulations
• Experience with engineering systems in accordance with ISO 1491 thermal management, mechanical noise/vibration control, electrical safety will be advantageous
• Experience in electro-mechanical motion systems design and optics is a plus
• Experience in material selection and biocompatibility is a plus
• Strength in problem-solving and decision-making
• High energy level, attention to detail and a sense of urgency
• Good collaboration skills, organized and detailed with willingness to learn
• Demonstrate strong interpersonal skills.