COMPANY OVERVIEW
Checkpoint Surgical is a privately held medical device company based in Cleveland, Ohio. The company works with surgeons to advance the science and practice of peripheral nerve care through research, education, and innovative product development. Checkpoint Surgical’s state-of-the-art nerve care products have become the standard of care for peripheral nerve surgery. The company actively develops and brings to market new products to support the entire continuum of intraoperative nerve care.
Position: Product Development Manager
Department: Engineering
Location: Cleveland, OH
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The primary responsibility of this team member will be project management, development, and launch of innovative, intra-operative, nerve repair and protection devices. This will include:
- Lead a development team tasked with the design, development, and launch of nerve repair medical devices including sterile packaged instruments and implants.
- Project and resource management for product development projects according to Design Control procedures.
- Manage project budgets and schedules to carry out programs on a timely basis.
- Manage designs for reliability, regulatory compliance, manufacturability, and cost for current and newly developed products.
- Create and execute protocols for testing/analyzing products to demonstrate function and required regulatory compliance.
- Coordinate product evaluation and development with developing surgeons.
- Creation and management of design control documentation for products.
- Coordinates compliance with electrical safety requirements and Human factors documentation for new and existing designs as applicable.
EXPECTED AREAS OF COMPETENCE
- Full working knowledge of and significant level of experience with bac 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 problems.
- Ability to develop project schedules, and to assess and manage a 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.
- Leadership in the creation and improvement of internal processes.
- Microsoft Office Suite, CAD (Solid Works preferred).
EDUCATION AND EXPERIENCE
- Bachelor’s degree in Biomedical Engineering [BC1] or related field.
- Minimum of 5-7 years of experience with medical development and 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.
