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Senior Product Development Engineer

2 months ago

Independence, United States Checkpoint Surgical Full time

Company and Position 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 products at:


Principal Duties and Responsibilities:

The primary responsibility for 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 integration of software, hardware, usability, and interface design.
  • Will be responsible for supporting 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.
  • Manage 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.
  • Ability to work collaboratively both across internal departments and with our clinical users on the research and development of new products.
  • Working within a quality management system such as ISO 9001 or 13485.
  • Experience designing products to meet safety standards such as IEC 60601.
  • Ability to follow and manage project schedules
  • 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.
  • Familiarity with electronics lab procedures including ESD controls and PPE use.
  • Schematic Capture and PCB layout experience, is preferred.
  • Microsoft Office Suite.


Education and Professional Requirements:

  • Bachelor’s Degree in Electrical Engineering or related field.
  • 6 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)
  • Dental insurance
  • Employee assistance program
  • Health insurance
  • Health Savings Account
  • Life insurance
  • Paid time off
  • Retirement plan
  • Vision insurance


Schedule:

  • Monday to Friday


Supplemental pay types:

  • Bonus pay


Ability to commute/relocate:

  • Cleveland, OH (Required)


Education:

  • Bachelor's degree in Electrical Engineering or similar (Required)


Experience:

  • Product development: 6 years minimum
  • Laboratory experience: desired
  • Manufacturing Experience: desired


Work Remotely:

  • No