Director of Verification & Validation
About the role
The BiVACOR Director of Verification & Validation (DVV) will implement engineering objectives and initiatives related to the BiVACOR program to drive the product through clinical trial. The DVV will provide technical direction, guidance and support for engineering initiatives, staff, vendors, and external consultants, with a focus on directing the verification and validation (V&V) activities of the implantable components of the BiVACOR Total Artificial Heart (TAH).
Responsibilities
- Provide technical direction, guidance and support for engineering initiatives, staff, vendors, and external consultants, with a focus on directing the verification and validation (V&V) activities of the implantable components of the BiVACOR Total Artificial Heart (TAH).
- Consult with top management and make recommendations to progress the V&V of the implantable TAH.
- Create functional strategies, develop budgets, policies and procedures for the V&V activities of the implantable TAH.
- Work with quality management to ensure compliance to the relevant quality standards and regulatory agencies.
- Be responsible for the implementation of CFR 820.30 – Section C - design control particularly as it applies to the V&V aspects of the implantable subsystems.
- Support the engineering team to lead, teach best-practice engineering development, and V&V into the TAH development cycle.
- Monitor metrics within the development to identify potential issues and concerns with performance, scalability and quality, and work with the team to devise plans so that the teams can tactically address problems in a timely and effective fashion.
- Lead, manage, and oversee external V&V activities, as well as develop and review V&V documentation.
- Transform the project from the prototype stage to a clinical environment.
Requirements
- Bachelor’s degree or higher in Engineering (Biomedical or Mechanical) – Required.
- 8+ years’ experience in Class III medical device V&V – Required.
- Experience in Medical Device Industry and knowledge of engineering design, test, and safety standards (IEC 60601-1, FDA Regulations, ISO 14708, ISO 13485, ISO 9001) – Required.
- Understanding of design controls, including design (customer and product) requirements, performance specifications, and V&V testing – Required.
- Start-up company experience - highly desirable.
- Strong technical writing ability for designing V&V protocols and reports – Required.
Qualifications
- Bachelor’s degree or higher in Engineering (Biomedical or Mechanical) – Required.
- 8+ years’ experience in Class III medical device V&V – Required.
- Experience in Medical Device Industry and knowledge of engineering design, test, and safety standards (IEC 60601-1, FDA Regulations, ISO 14708, ISO 13485, ISO 9001) – Required.
- Understanding of design controls, including design (customer and product) requirements, performance specifications, and V&V testing – Required.
- Start-up company experience - highly desirable.
- Strong technical writing ability for designing V&V protocols and reports – Required.
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
Pay
The expected salary range for this position is $180,000 to $230,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Schedule
This role is based on-site at BiVACOR’s Huntington Beach, California headquarters and reports to the Manufacturing Engineering Manager.
Company
BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.