Bivacor Inc

Director of Verification & Validation

Huntington Beach. Posted 4 months ago

The role

The Director of Verification & Validation will implement engineering objectives to drive the BiVACOR Total Artificial Heart through clinical trial. This person will provide technical direction for V&V activities of implantable components and manage in-house and external V&V efforts.

What you will do

  • Implement engineering objectives and initiatives to drive the product through clinical trial
  • Provide technical direction, guidance and support for engineering initiatives, staff, vendors, and external consultants
  • Direct verification and validation activities of the implantable components of the TAH
  • Consult with top management and make recommendations to progress V&V
  • Create functional strategies, develop budgets, policies and procedures for V&V activities
  • Implement CFR 820.30 design control for implantable subsystems
  • Work with quality management to ensure compliance to quality standards and regulatory agencies
  • Manage external V&V activities and develop and review V&V documentation
  • Lead and teach best-practice engineering development and V&V into the TAH development cycle
  • Monitor metrics to identify potential issues with performance, scalability and quality

Required qualifications

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

Nice to have

  • Start-up company experience

Benefits

  • 401(k) with company matching
  • Medical, dental, and vision insurance
  • Health Savings Account (HSA) & Flexible Spending Account (FSA)
  • Life insurance & Employee Assistance Program
  • Generous paid time off

Before you apply

  • Relocation benefits are not available for this posting

About the company

BiVACOR is developing a total artificial heart technology. The team works on an implantable technology capable of saving lives.