Principal Duties and Responsibilities

The primary responsibility for of this team member will be to lead the development and launch of innovative nerve stimulation and protection devices. This will include:

• Design and development of new electro-stimulation medical devices
• Project and resource management for product development projects of according to Design Control procedures.
• Develop and manage project budgets and schedules to carry out programs on a timely basis.
• Manage design for reliability, regulatory compliance, manufacturability, inspectability and cost for current and developed products
• Conduct root cause analysis to support current product lines
• Coordinate product evaluation and development with surgical staff users
• Creation and management of design control documentation for the products. Coordinates compliance applicable requirements and Human factors documentation for new and existing designs.

Expected Areas of Competence

• Working knowledge of and significant level of experience with new product development including project management.
• Demonstrated ability to methodically investigate, determine solutions and resolve complex problems using current and new technologies.
• Ability to develop or identify new technologies to address customer needs
• Ability to develop project schedules, and to assess and manage cross functional team’s progress on assignments relative to project schedule.
• Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors.
• Demonstrated good written and verbal communication skills including presentation skills.
• Working knowledge of Electrical Safety standards.

Education and Professional Requirements:

• Bachelor’s Degree in Electrical, Biomedical Engineering or related field.
• 5-7 years experience with product development and design. Electrical device experience strongly preferred.
• Minimum 3 years of experience with FDA/GMP regulated medical device design
• Track record of project leadership and commercialization, including manufacturing support, of medical devices
• Project management including planning, execution, budgetary constraints.
• Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
• Desire to work in a fast paced, small company environment as an integral part of a team