Reporting to the R&D Manager, the purpose of this position is to support and manage activities for the design and development of catheters and related products, including mechanical design, testing, documentation, drawings, and other activities to bring products from concept to commercialization. In addition, the role of this position is to liaise with contract manufacturers and suppliers and to assist in the development of internal and external test methods, as further described in the responsibilities section below.
Duties and Responsibilities
Conceptualize, design, and develop innovative interventional catheters, including the establishment of design requirements, prototype developments, verification testing, and risk assessments.
Use modeling software (such as Solidworks) to make formal drawings of products and their components, as well as test fixtures and apparatuses needed for testing.
Develop appropriate test methods for product evaluations, write and execute test protocols and test reports required per GMP and regulatory submissions.
Establish timelines and ensure adherence to timely execution.
Collaborate with colleagues and physicians in both pre-clinical (animal) and clinical programs in order to evaluate technology in animal and clinical use.
Work as an R&D team member (Catheter & Console teams), as well as with other functions within CryoTherapeutics to identify potential external vendors and assist in developing productive and efficient relationships with vendors to ensure good quality products are delivered on time.
Qualifications
Education: Bachelor's degree in Biomedical / Mechanical Engineering, a Master’s degree is preferred.
Experience in mechanical designs and development, preferably within medical device companies.
Relevant technical and practical experience in materials (plastics, adhesives, and associated processes), and mechanical (small part) design is desired.
Good knowledge of software modelling for mechanical designs and components, as well as fluidic systems. Computational Fluid Dynamics modeling is a plus.
Familiarity with risk assessment tools, FMEA’s, Hazard Analysis, etc. is a plus.
Flexible, detail-oriented, problem solver, with a roll-up-sleeves attitude
Team-building and organizational skills.
Excellent oral and written communication skills in English. Proficiency in French or another language is an asset.
Working Conditions
Full-time position – standard working hours apply.
Work in the office/lab in Loncin or another designated facility is required.
Some travel may be necessary at times (up to 25%).