Director of Verification & Validation

BiVACOR Inc; Huntington Beach (CA); Sur place; USD 180 000 - 230 000; Plein temps

Avantages offerts par ce poste

401(k) with company matching

Medical, dental, and vision insurance

HSA & FSA

Résumé du poste

BiVACOR in Huntington Beach, CA is seeking a Director of Verification & Validation (DVV) to lead V&V for the implantable total artificial heart. You will set strategy, guide engineering teams, and ensure CFR 820.30 design controls throughout the development cycle.

The role requires a Biomedical or Mechanical engineering degree and 8+ years in Class III medical device V&V, with IEC 60601-1, FDA regs, ISO 13485, and strong technical writing.

Qualifications

• Bachelors degree or higher in Engineering (Biomedical or Mechanical).
• 8+ years experience in Class III medical device V&V.
• Experience with medical device standards (IEC 60601-1, FDA Regulations, ISO 14708, ISO 13485, ISO 9001).
• Understanding of design controls, requirements, performance specs, and V&V testing.
• Startup company experience is highly desirable.
• Strong technical writing ability for designing V&V protocols and reports.

Responsabilités

• Lead verification and validation activities for implantable TAH.
• Provide technical direction to engineers, vendors, and external consultants.
• Develop budgets, policies and procedures for V&V activities.
• Ensure CFR 820.30 design control compliance for V&V aspects.

Connaissances

Biomedical Engineering

V&V Class III

Medical device standards

Design controls

Technical writing

Startup experience

Formation

Engineering degree

Description du poste

Help Us Build the Future of the Human Heart.

At BiVACOR, we19re developing the worlds most advanced total artificial heart 4cs a technology capable of saving millions of lives around the world. Were a team united by purpose, working on something truly unprecedented. Every process you optimize, every validation you lead, and every engineer you mentor plays a direct role in giving patients another shot at life. If thats the kind of work that gets you out of bed in the morning, we think you belong here.

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).

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 projects success.

What You Bring

• Bachelors 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.

What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

• 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

This role is based on-site at BiVACORs Huntington Beach, California headquarters and reports to the Manufacturing Engineering Manager. 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. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.