Autotransfusion System

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AutoTransfusion System (ATS) Project Head (M/F/d)

Position Summary

A Project Head is a point of accountability for a project, with strong technical and business expertise responsible for guiding the full core team through the PDP stage-gates. This is a critical role in supporting a future state innovation strategy that depends on rapid decision-making, agility, delivery, and effective leadership.

The ATS Project Head is responsible for the comprehensive execution and oversight of the Product Development Process (PDP) for the new generation Auto Transfusion System (NG ATS). The Project Head drives technical and commercial excellence by overseeing and connecting all key functional teams, taking a system-level view of products and ensuring that all system components function cohesively. In addition, the role proactively drives product innovation in anticipation of evolving clinician, regulatory and payer needs, and in alignment with LivaNova's strategic business goals.

General Responsibilities
- Spearhead project execution, responsible for all key executional decisions related to the PDP
- Strategically balance business and innovation objectives with adherence to desired scope, budget, and timelines; proactively sequence deliverables to adhere to these timelines
- Regularly engage senior leadership to understand their expectations and provide updates on PDP program status and challenges
- Proactively communicate project execution decisions and status updates to the product development core team and other relevant stakeholders
- Ensure all project deliverables meet the necessary rigor and quality
- Drive technical excellence and innovation within the product development process, ensuring that projects are aligned with strategic business objectives
- Maintain a system-level understanding of all technical aspects and integrations, ensuring that individual components are designed and perform in harmony with the entire system
- Ensure project delivery meets business and market needs, balancing technical and commercial considerations
- Manages third parties involved in the development process

Skills and Experience
- Bachelor's degree in engineering; an advanced degree (MBA or similar) preferred to combine technical depth with strategic business acumen
- Several years of experience in technical project management within the medical device industry or other heavily regulated industries (e.g., Pharmaceutical, Aerospace, Automobile, etc.)
- In-depth knowledge of complex system development, including the integration of hardware, software, and firmware components. Proven experience in navigating and managing cross-disciplinary engineering challenges
- Demonstrated ability to assess business cases, evaluate contracts, and align technical projects with overarching business objectives. Strong understanding of financial implications and market dynamics related to product development
- Ability to source, qualify, contract and manage third parties involved in technology development
- Extensive experience leading large, cross-functional, and geographically dispersed teams in a fast-paced and highly technical environment. Ability to influence and engage senior leadership and diverse stakeholders effectively
- Comprehensive understanding of U.S. FDA regulations, European Union Medical Device Regulation (EU MDR), and other relevant global standards
- Proven track record of successfully managing projects from concept to market, consistently delivering within scope, budget, and time constraints
- Frequent travel may be required, including long distance

WHAT WE CAN OFFER YOU

In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

- A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
- Exposure to a _State-of-the-Art _medical device development process, in close co-operation with international clinicians
- Competitive base salary
- Variable short-term & long-term incentives
- Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements

Our commitment to Diversity & Inclusion:

- LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination._

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