Endovascular Engineering, Inc. ("E2"), is a mission-driven, venture-backed company focused on the development and deployment of next generation clot removal technologies that target venous thromboembolism.
Summary:
The Principal R & D Engineer is responsible for the design and development of new and improved products and procedures to address vascular diseases and conditions using minimally invasive techniques. This role provides technical leadership based on in depth knowledge of engineering principles and medical device development.
Principal Duties and Responsibilities:
Design and iterate novel product designs and solve complex engineering problems to lead the development of catheter-based products that address clinical needs of patients and ease of use needs of users in the cath lab.
Plan, organize, and lead projects of substantial variety and complexity, directing team members and coordinating activities.
Prepare complex technical documentation, including manufacturing instructions, test methods, protocols, and reports to support design control activities and regulatory submissions.
Provide periodic cross-functional updates regarding project status.
Contribute to the company's intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice.
Lead discussions with physicians regarding clinical needs and feedback on product development through testing and product demonstrations.
Education / Experience Requirements:
Bachelor's Degree in Engineering (Mechanical or Biomedical preferred)
At least 10 years' experience leading design and development of disposable medical device products from early development through product launch.
Comprehensive understanding of medical device design including catheter materials, components, and construction methods.
Experience with medical device design control process and DHF management.
Proficiency with Solidworks. Ability to read and interpret engineering specifications, drawings, manufacturing instructions and technical analyses.
Demonstrated ability of working with suppliers, including understanding of capabilities, materials, and fabrication processes.
Knowledge of problem-solving techniques such as design of experiments and descriptive statistical data analysis techniques.