Director of Verification & Validation

About the Company

BiVACOR is developing the world’s most advanced total artificial heart — a technology capable of saving millions of lives around the world. We are a team united by purpose, working on something truly unprecedented to give patients another shot at life.

Responsibilities

• Implement engineering objectives and initiatives to drive the product through clinical trials
• Provide technical direction and guidance for engineering initiatives, staff, vendors, and external consultants
• Direct verification and validation (V&V) activities of the implantable components of the Total Artificial Heart (TAH)
• Create functional strategies, develop budgets, policies, and procedures for V&V activities
• Implement CFR 820.30 design controls and work with quality management to ensure regulatory compliance
• Lead and teach best-practice engineering development and V&V into the TAH development cycle
• Monitor development metrics to identify issues with performance, scalability, and quality
• Manage in-house and external V&V efforts and vendor assignments

Requirements

• Bachelor’s degree or higher in Biomedical or Mechanical Engineering
• 8+ years of experience in Class III medical device V&V
• Knowledge of engineering design, test, and safety standards (IEC 60601-1, FDA Regulations, ISO 14708, ISO 13485, ISO 9001)
• Understanding of design controls, including requirements, performance specifications, and V&V testing
• Strong technical writing ability for designing V&V protocols and reports

Preferred Qualifications

• Start-up company experience