R&D Engineer

2 weeks ago

Kitchener ON MA, Waterloo region, 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.

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.

Position:
R&D Engineer

Location:
Hybrid – Office in Kitchener, Ontario, Canada

Role Overview:
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.

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.

Ideal Candidate Profile:
· 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.
· 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, 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).

Qualifications:
· Bachelor's degree in Engineering or a related field.
· 3 years of experience in engineering, preferably within the medical device sector.
· 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 a 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 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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