Director of Verification & Validation
About The Position
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). The DVV will consult with top management and make recommendations to progress the V&V of the implantable TAH. The DVV will create functional strategies, develop budgets, policies and procedures for the V&V activities of the implantable TAH. The DVV will 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 and will work with quality management to ensure compliance to the relevant quality standards and regulatory agencies. The DVV will be required to be hands-on to support team to manage external V&V activities, as well develop and review V&V documentation. The high-level responsibility of this position will require a broad knowledge and transparent decision making in different aspects of engineering, while maintaining a focus on V&V. The role requires the DVV to be hands-on with the engineering teams to lead, teach best-practice engineering development, and V&V into the TAH development cycle. The DVV will 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. This role requires the authoritative management of the in-house and external V&V effort and external consultant assignments and vendors while transforming the project from the prototype stage to a clinical environment. BiVACOR is looking for a motivated people leader who is keen to contribute to this early stage and dynamic project. This role requires creativity and strong organizational talent. Being able to find optimized solutions in a multidisciplinary and dynamic development will be vital to the project's success.
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.
- Strong technical writing ability for designing V&V protocols and reports – Required.
Nice To Haves
- Start-up company experience - highly desirable.
Responsibilities
- Implement engineering objectives and initiatives related to the BiVACOR program to drive the product through clinical trial.
- 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.
- 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.
- Work with quality management to ensure compliance to the relevant quality standards and regulatory agencies.
- Be hands-on to support team to manage external V&V activities, as well develop and review V&V documentation.
- 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.
- Authoritatively manage the in-house and external V&V effort and external consultant assignments and vendors while transforming the project from the prototype stage to a clinical environment.
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
- Discretionary annual bonus may be available based on individual and Company performance.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
