Job Description
Job Description
About Endovascular Engineering
Endovascular Engineering (E2) is a mission-driven, venture funded medical device company dedicated to developing and deploying next-generation vascular thrombectomy solutions. Our innovative solutions aim to improve patient outcomes in pulmonary embolism and other vascular conditions. The company is in Menlo Park, CA.
Job Description
The Senior 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.
Responsibilities
Design, prototype and develop novel design solutions for catheter-based products to improve performance and ease of use in clinical procedures.
Work as part of a cross-functional team to develop and evaluate product designs through verification and validation testing
Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions
Provide periodic updates regarding project status
Contribute to the company's intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice
Interact with physicians regarding product development, testing, and product demonstrations
Train other team members on product assembly; troubleshoot assembly process issues
Maintain Design Control activities for new product development from initial concept through commercialization. These activities may include the following: developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.
Work collaboratively with other company functions as needed, including R&D, Marketing, Operations, Quality, Clinical and Regulatory to ensure project success.
Support the development and upkeep of the Company's Quality System in conjunction with the Company's Quality Department.
Qualifications
At least 5 years' experience leading development of disposables medical device products.
BS Engineering (Mechanical or Biomedical)
Experience with design and process development of medical device catheters.
Experience with FDA and ISO standards for medical device design controls and manufacturing
Working knowledge of common catheter materials and construction methods.
Successful track record of leading development of medical disposable products from early development through product launch
Self-motivated with ability to work independently and with minimal supervision