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