Lead Mechanical Engineer, Medical Devices

🩺 What this role is about:

We're embarking on an exciting new chapter at CardioVia, and this is your opportunity to lead! At CardioVia, we're on a mission to make heart treatments safer and smarter. Our FDA-cleared device, ViaOne, enables physicians to access the heart’s surface safely and reliably, unlocking a new frontier for life-saving cardiac therapies. We're looking for a visionary, hands-on mechanical engineering leader to drive our continued innovation.

💼 What you’ll be doing:

• Perform hands on product development from concept through production

• Conduct pre-clinical and clinical testing activities, including protocol development and report writing.

• Translate complex clinical needs into robust engineering solutions

• Manage and mentor a multidisciplinary R&D team

• Prepare and review technical documentation, reports, and product specifications

• Oversee testing to ensure compliance with regulatory and quality standards

• Lead manufacturing scale-up

• Manage vendors and subcontractors

• Collaborate with physicians to optimize real-world performance.

• Work closely with consultants, clinical, regulatory and operations teams.

🧠 What you bring:

• Degree in Mechanical Engineering (B.Sc./M.Sc.)

• 5+ years in medical device R&D with full product lifecycle experience

• Proven track record taking products from concept to market

• Demonstrated experience managing vendors and subcontractors

• Strong understanding of DFM, quality systems, and scaling for manufacturing

• Excellent technical writing and documentation skills

• Great communication skills and a practical, get-it-done and fast approach

• Passion for innovation and a deep understanding of medical devices' clinical relevance and application

• Demonstrated ability to work independently, and effectively under tight and changing deadlines

🌎 Why now?

CardioVia is entering a high-growth phase. With FDA clearance secured and U.S. commercialization underway, we’re building the core team that will shape our next chapter. This is a rare opportunity to take on a critical role at a company that's solving a real clinical problem and gaining serious traction doing it.