POSITION SUMMARY: The Principal Delivery System Engineer will drive design and development of an catheter based delivery system for a thrombectomy device at a start up poised to enhance treatment options for PE and DVT patients. The successful candidate must possess a passion for medical device engineering and a record of bringing devices from concept to clinical release. A successful candidate will take initiative, display a positive attitude, and have exceptional communication skills.

Roles And Responsibilities

• Driving delivery system expertise on a team developing novel devices for thrombectomy applications.

• Empower engineers and teams to make the right technical decisions in order to meet project objectives

• Drive projects to completion by forming a project plan, contributing to schedules, and identifying and removing roadblocks

• Collaborate with cross functional teams including QA, RA, Mfg., Marketing, and Clinical

• Provide technical guidance on failure analysis and test method development

• Utilizing skills to develop a ancillary product for thrombectomy catheters and structural heart catheters.

• Utilize DRM / DFSS skills to design for scalability and manufacturability.

• Invent novel designs to overcome technical challenges and meet user needs

Required Qualifications

• B.S. in Mechanical Engineering or similar degree

• 10+ years of experience developing catheter delivery systems in the Medical Device Industry with an understanding if injection molded parts and/or trigger mechanisms

• Experience with product development methodologies including design controls, risk management, and V&V

• Familiarity with FDA regulations and ISO quality standards

• Demonstrated experience leading devices from concept to launch

• Excellent verbal and written communication skills

Preferred Qualifications

• Experience in a startup environment wearing multiple hats

• Strong mechanical engineering skills with experience in catheter design, machined components, injection molded components, extruded polymer tubing, and design for manufacturability

• Thrombectomy experience on DVT and/or PE products