Senior Design Engineer
7-10 years experience in designing surgical instruments in the fields of cardiology, cardiovascular surgery, endoscopy, laparoscopy, and orthopedics. Knowledge of catheter based products and mechanical disposable devices are desirable.
Design and develop instruments for a wide variety of device OEMs Communicate with customers and surgeons to understand clinical requirements.
Define design parameters.
Ensure the correct product is provided to the customer.
Ensure compliance with FDA regulations, and support 510(k) submissions or IDE clinical studies.
Create and maintain project plans and FDA compliant Design History Files.
Develop appropriate mechanical and functional test protocols.
Coordinate the activities required to fabricate test parts and complete design testing.
Work in conjunction with manufacturing during the design stages of product designs.
Responsible for all designs from concept development through product launch.
Perform bench-top development, prototyping, modeling and testing.
Strong communication and interpersonal skills.
Ability to interact with various customers and surgeons.
Experience in the creation of solid models (SolidWorks), analyzing designs (COSMOS) and detailed drawings for new designs, maintain design control documentation and project files adhering to FDA and ISO design control requirements.
Bachelor’s degree in Mechanical or Biomedical Engineering required.
Please send a pdf of your resume.