Location: Cleveland, OH
- 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.
- 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