Principal R&D Engineer

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™ , an FDA Breakthrough Designated Technology, 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 treat stroke. ● The Vena Balloon Distal Access Catheter™ has combined both a distal access catheter and balloon guide catheter into one, bringing the balloon closer to the clot, reducing residual clots, increasing first-pass success rate, and cutting costs. Role Overview: As a Principal R&D Engineer dedicated to our MicroAngioscope product line , you will drive all facets of research and development for novel minimally invasive devices, from conceptual design to completed Design Verification and Validation. This senior-level role requires a blend of technical expertise, leadership, and creative problem-solving, ensuring each phase—from concept generation to commercialization—is executed with innovation and precision. Key Responsibilities: ● 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. ● Contribute to the company’s intellectual property portfolio, ensuring robust protection and innovation documentation. ● Provide ongoing support for R&D sustaining activities, addressing any issues in commercial production lines. ● Manage and track deliverables from both internal and external teams to align with product design changes and requirements. ● Offer technical leadership and mentorship to junior engineering staff, fostering best practices within the R&D team. Ideal Candidate Profile: ● Strong experience in R&D related to catheters or endoscopes within the medical field, both designing and building. ● Skilled in creating and implementing design verification and validation test flows. ● Demonstrated understanding of clinical anatomy in the vascular system. ● 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, IEC62304, ISO 14971, ISO 10555, ISO 8600, 21 CFR 820, and ISO 13485. ● Experience in drafting and maintaining Design History Files (DHF) and Device Master Records (DMR). ● Experience in neurovascular design, including nitinol, hydrophilic coatings and variable stiffness sheaths Qualifications: ● Bachelor’s degree in Engineering or a related field. ● 5 years of experience in engineering, preferably within the medical device sector. (Additional experience leading projects or teams is highly valued for this principal-level role.) ● Proven capability in rapid design iteration and providing impactful design recommendations. ● 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 an ISO 13485 certified quality management system. ● Excellent communication skills, both verbal and written, with demonstrated leadership abilities. ● 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 patients’ lives. We offer competitive salaries, comprehensive benefits, a supportive environment that fosters innovation and personal growth, and the opportunity to shape the future of neurointerventional procedures. If you’re looking to make a tangible difference in the medical field, join us in paving the way for the future of stroke treatment.

Location: Kitchener, CA

Posted Date: 4/20/2025