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.

Vena Medical

About Us

Latest Jobs

Principal R&D Engineer