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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 Engineer
Department:      Engineering
Salary Range:     $75,000 – $90,000
Location:             Cleveland, OH

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The primary responsibility of this team member will be to contribute to the development and launch of innovative surgical devices for peripheral nerves. This will include:

  • Design and development of new medical devices for nerve repair.
  • Project and resource management for defined product development projects according to Design Control procedures.
  • Manage design for reliability, regulatory compliance, manufacturability, inspect ability and cost for current and developed products.
  • Testing & analysis of products and prototypes to demonstrate function and required regulatory compliance.
  • Coordinate product evaluation and development with surgical staff users.
  • Creation of design control documentation for developed products.
  • Prepares regulatory submissions for products and clinical studies, including IDE’s, 510(k)’s, PMA’s, HDE’s, and Annual Reports, as needed.

EXPECTED AREAS OF COMPETENCE

  • The primary responsibility for of this team member will be to contribute to the development and launch of innovative surgical devices for peripheral nerves. This will include:
  • Design and development of new medical devices for nerve repair.
  • Project and resource management for defined product development projects according to Design Control procedures.
  • Manage design for reliability, regulatory compliance, manufacturability, inspect ability and cost for current and developed products.
  • Testing & analysis of products and prototypes to demonstrate function and required regulatory compliance.
  • Coordinate product evaluation and development with surgical staff users.
  • Creation of design control documentation for developed products.
  • Prepares regulatory submissions for products and clinical studies, including IDE’s, 510(k)’s, PMA’s, HDE’s, and Annual Reports, as needed.

EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering, Materials Science, or related field.
  • 2-5 years’ experience with product development.
  • Project management including planning, execution, budgetary constraints.
  • Understanding of medical device DHF, DMR, and DHR files management and documentation requirements a plus.
  • Desire to work in a fast paced, small company environment as an integral part of a team.
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