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New Product Development Manager

Cleveland, OH

Responsibilities

  • Leads cross functional teams and external development resources in developing product design input requirements, specifications, generating design concepts, prototype builds, pre-clinical evaluations, and transferring to manufacturing.
  • Ensure products meet customer, company, and regulatory requirements.
  • Develops and manages project budgets and timelines; communicating progress across the organization.
  • Oversees the creation of product Design History Files (DHF).
  • Performs analysis and establishing test plans to demonstrate products meet all requirements.
  • Provides project management in development of new products.
  • Provides technical support for customers and clinical trial sites as needed.
  • Supports the design transfer to manufacturing.
  • Identifies and qualifies external development partners.
  • Maintains and improves the product development process within the SPR quality management system.

Requirements:

  • Bachelor’s Degree in Engineering discipline (Mechanical, Electrical, Biomedical, or related field).
  • Minimum 10 years of experience with FDA/GMP regulated medical device development.
  • Management experience leading product development teams/functions.
  • Project management experience including planning, execution, and meeting time and budget constraints.
  • Proficient with medical device DHF and DMR management and documentation requirements.

Why Join Our Team?

  • Entrepreneurial work environment – A growth oriented and collaborative atmosphere in the medical device industry!
  • Ability to work with game changing technology
  • Competitive compensation and benefits
  • Employee Wellness Program
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