Product Development Engineering

3 weeks ago

Kitchener ON, Canada Vena Medical Full time

About Us: Vena Medical is at the forefront of revolutionizing stroke treatment through cutting-edge catheter-based technologies. Our commitment to innovation has inspired our flagship products, the Vena MicroAngioscope™️ and the Vena Balloon Distal Access Catheter™️. These pioneering technologies provide neurointerventional physicians with advanced tools for treating stroke, marking a significant leap forward in medical technology. As we continue to expand our product line and impact on the medical community, we're looking for exceptional talent to join our dynamic team.

The Vena MicroAngioscope™️ is providing physicians with a new set of eyes, the world’s smallest camera that delivers a live imaging-feed from inside veins and arteries to help them treat stroke.

Hybrid – Office in Kitchener, Ontario, Canada
 
As an R&D Engineer, you will engage in all facets of research and development for novel minimally invasive devices. This role demands a creative approach to design and problem-solving, ensuring that each development phase from concept generation to commercialization is executed with precision and innovation.
 
Drive the R&D of new medical devices, from conceptualization and prototype design to Design Freeze and commercialization, creating user needs, design inputs, design outputs as well as verification and validation methods.
· Develop comprehensive plans, test flows and perform rigorous testing for design verification and validation.
· Provide ongoing support for R&D sustaining activities, addressing any issues in commercial production lines.
· Strong experience in R&D related to catheters or endoscopes within the medical field.
· Skilled in creating and implementing design verification and validation test flows.
· Knowledge of clinical scenario replication and anatomy in test setups.
· Proficient in writing comprehensive test methods and conducting Failure Mode & Effects Analysis.
· Familiarity with regulatory requirements, including IEC 60601, ISO 14971 ISO 10555, ISO 8600, 21 CFR 820 and ISO 13485.
· Bachelor's degree in Engineering or a related field.
· 3 years of experience in engineering, preferably within the medical device sector.
· Strong proficiency in SolidWorks and a robust understanding of experimental design and statistical analysis.
· Demonstrated creativity in engineering design and problem-solving.
· Demonstrated experience in adhering to a ISO 13485 certified quality management system.
· A proactive and results-oriented approach to projects, with a keen interest in biomedical technology.
 
Why Join Vena Medical?
Vena Medical is not just a workplace. It's a ground-breaking community where your work directly contributes to the advancement of medical treatments and improving patient’s lives. We offer competitive salaries, comprehensive benefits, flexible work-life balance and a supportive environment that fosters innovation and personal growth. If you're looking to make a tangible difference in the medical field, join us in paving the way for the future of neurointerventional procedures.

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