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 Engineer/Senior Engineer will report to the Lead, Engineer, Systems Engineering.
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.
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.
