Senior Design Engineer

REQUIRED BACKGROUND

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.

RESPONSIBILITIES

• Design and develop instruments for a wide variety of device OEMs
• Communication with customers and surgeons understanding the clinical issues /li>
• Defining the design parameters
• Ensuring the correct product is provided to the customer

POSITION REQUIREMENTS

• Ensure compliance with FDA, and to support 510(k) submissions or IDE clinical studies.
• Create and maintain project plans and FDA compliant Design History Files.
• Develop appropriate mechanical test protocols
• Coordinate the activities required to fabricate test parts and complete mechanical testing.
• Work in conjunction with manufacturing during the design stages of product designs.
• Responsible for the all designs from concept development through product launch.
• Perform bench-top development, prototyping, modeling and testing within house facilities.
• 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.

EDUCATION

Bachelor’s degree in Mechanical or Biomedical Engineering required.