Product Development Manager

Checkpoint Surgical, Inc.

Job Posting

THE POSITION: Product Development Manager

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 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).

EXPERIENCE AND PROFESSIONAL REQUIREMENTS

• 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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Prescription drug insurance
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Ability to Relocate:

• Independence, OH: Relocate before starting work (Required)

Work Location: In person