Product Development Engineer - Electrical and Systems Engineering

Checkpoint Surgical, Inc. Job Posting

THE POSITION

Product Development Engineer

COMPANY OVERVIEW

Checkpoint Surgical is a privately held, Cleveland, Ohio based medical device company committed to providing surgeons with user-friendly, cost-effective devices to protect and repair nerve intraoperatively across the anatomy. We have built an enterprise that values innovation, creativity, and teamwork for the sake of our customers, investment partners and employees.

WHO WE ARE

Purpose:

We believe patients deserve surgical outcomes that preserve and restore optimal nerve function

Mission:

Advancing the science and practice of nerve protection and repair to improve the quality of life for patients and physicians

Vision:

To be the preeminent nerve protection and repair enterprise

Values:

Excellence, Passion, Purpose, Urgency, Service, Integrity, Respect Check out our company and products at: www.checkpointsurgical.com

KEY RESPONSIBILITIES

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

This will include:

Design and development of advanced medical devices for nerve care with focus on Electrical and Systems Engineering, including development and integration of software, hardware, usability, and interface design. Support new product development via engineering analysis, simulation, preparation and testing of prototypes, and other duties. This will require an understanding of the overall performance of products within the business and helping to identify potential areas of improvement. Design for reliability, regulatory compliance, manufacturability, testability, and cost for current and developed products. Creation of design control documentation including system requirements and functional analysis. Design, Analysis, and Testing of products and prototypes to demonstrate function and required regulatory compliance. Use project management skills to hit deadlines and meet project requirements.

EXPECTED AREAS OF COMPETENCE

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. Working within a quality management system such as ISO 9001 or 13485. Schematic Capture and PCB layout experience preferred. Familiarity with electronics lab procedures including ESD controls and PPE use. Experience designing products to meet safety standards such as

IEC 60601, EMC

Standards such as

IEC 60601-1-2

preferred. Experience with

IEC-62304

compliant software development preferred Ability to follow and manage project schedules Ability to work collaboratively both across internal departments and with our clinical users on the research and development of new products. 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. Microsoft Office Suite.

EXPERIENCE AND PROFESSIONAL REQUIREMENTS

Bachelor's Degree in Electrical Engineering or related field. 5 or more years' experience with new 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.

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Parental leave Vision insurance

Education:

Bachelor's (Required) Ability to

Relocate:

Independence, OH:

Relocate before starting work (Required)

Work Location:

In person