We’re looking for someone who is excited to embrace the unknown, innovate in the assistive device lower limb orthopedics space, and can take our proof-of-concept all the way to a commercialized class 1 medical device.

Responsibilities We are looking for a passionate puzzle-solver who specializes at the intersection of mechanical engineering and biomedical/medical engineering – specifically human lower limb anatomy – to serve as Engineering Lead in our research and development efforts. This is a fully hands-on position and opportunity to be a key driver of how our products are designed, built and scaled. We have achieved TRL7 with an MVP via various industrial partners and want to bring expertise in-house. You would advance progress to date to conceptualize, research, design, prototype, procure, and test mechanisms, structural parts, packages, and assemblies by choosing the right geometry, materials, parts, systems, and process. You would manage projects through to production while working both independently and in collaboration with the founder as well as external team. The talent to think out of the box while simultaneously adhering to orthopedic biomechanics and engineering principles is essential. The ability to communicate clearly and comfortably without reservation is a must. An interest in lower limb injury and the effect on active populations is a plus.

Qualifications · Master of Science in Biomechanical / Medical Engineering · 5+ years of applied industry experience preferably in lower limb orthopedic assistive devices · Proven ability to lead end-to-end product development process in MedTech environment · Design and implement hypothesis-driven experimental methods and data analysis plans that inform product development · Experience with UX development and user-centric design approach · SolidWorks proficiency · Mechanical stress analysis and modelling experience · Experience with various methods of prototype development including machining, additive manufacturing and hands-on fabrication. · Design for manufacturing experience with support for trials and transfer to contract manufacturers · Product validation experience · Strong experience working with and managing contract manufacturers and suppliers · Good understanding of manufacturing technologies and materials · PLM and QMS documentation and implementation · ISO 13485 QMS experience is an asset · Soft goods experience is an asset · Demonstrated understanding of FDA and Health Canada regulatory process · Experience with user evaluation protocol and testing processes · Ability to work in a “high uncertainty” environment and be self-motivated to create practical solutions. · Willingness to experiment and learn from experience, receive feedback and collaborate with an interdisciplinary team. · Interest in working in a start-up where change and unknowns are everyday standards · Enthusiasm for lifelong learning, problem-solving and stepping outside your comfort zone · This is a hybrid position – working both in person and remotely

If you fit this description – we want to meet you! Please send your resume and cover letter explaining why you’re a great fit to Jolanda Peters at Jpeters@telus.net.