Interesting opportunity with a growing, commercial stage company that is a leader in catheter delivered, endoscopically guided treatment of atrial fibrillation. Excellent opportunity to join a technologically rich company with sophisticated disposables and capital equipment sold in the US and internationally. We are seeking a talented, hands-on and enthusiastic catheter engineer with medical device development capabilities. You’d join an expanding developer of innovative systems that have successfully treated thousands of patients with life threatening cardiac arrhythmias.
The position reports to the Director of R&D in a highly collaborative work environment. This technically challenging role requires a highly motivated engineer who wants to play a key role developing concepts and prototypes, and will participate in all stages of the design, transfer to manufacturing and regulatory approval of new devices. Responsibilities include ideation and invention, solving unique technical challenges, conducting required benchtop/preclinical testing to prove safety and efficacy, and support of regulatory submissions. This position requires strong analytical and problem-solving skills and detailed knowledge of catheter requirements and construction. The candidate will need to effectively collaborate with a cross-functional team including engineers and technicians in achieving objectives.
- BS or MS in Plastics, Mechanical, Biomedical Engineering or an equivalent combination of education and experience.
- Successful industrial experience designing and commercializing complex, multi-lumen catheters or other intricate disposable devices such as endoscopic, vascular or cardiac catheters.
- Demonstrated ability to take projects from concept through product realization.
- Knowledge of plastics used in medical applications, catheter bonding and assembly operations strongly desired.
- 3D CAD modelling such as SolidWorks is desired.
- Good written and verbal communication skills with the ability to write clear reports, specifications, and proposals and effectively discuss them with other members of a multi-disciplinary team (R&D, Manufacturing, QA, Clinical, Marketing).
- Working knowledge of regulatory requirements for medical devices.
- Exposure to the development of radio frequency ablation systems or electroporation systems is a plus.
- Basic understanding of statistics for design applications is desired.