Senior R&D Engineer, Catheters

• Provide technical leadership for the design and development of medical devices
• Assist in the transfer of new products from R&D to production
• Establish processes and manufacturing documentation for new catheter products
• Identify processes/materials to fabricate new products
• Use CAD software (Solidworks preferred) for part and assembly design and detail drawings
• Perform experiments to determine validity of designs
• Provide technical leadership for development projects
• Define product requirements
• Design and development of tooling
• Perform or manage design verification, equipment qualification and product and process validations
• Prepare and maintain product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
• Supervise and advise team members and technicians as necessary
• Comply with applicable FDA and international regulatory laws/standards
• Work directly with physicians to determine design inputs and/or design changes
• Other duties as assigned or required

• Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience
• 3-10 years industry experience with a medical device company
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Prior experience with non-invasive medical devices (catheters)
• Ability to present/teach detailed technical information, to all levels of company personnel and customers

Prior experience working with neurovascular catheter (especially balloon catheters)

• Medical Insurance, Dental Insurance, and Vision Insurance, 100% paid for employee
• 401K Plan