Desired Start Date: Dec 2024

Location: San Carlos CA

We believe the future of the operating room lies in the hands of the empowered surgeon. They are bolstered with complete control, renewed confidence, and technology adaptable to any situation.

Our Maestro System delivers this empowerment, resulting in improved operating room efficiency and surgical care for patients - We are using tomorrow's technology to change surgery today.

Our blended French-American team is passionate about building this future. Together we are pushing the boundaries in a fast-paced yet focused and deliberate environment. We challenge ourselves often and celebrate our achievements. We believe that communication and planning are as important as execution.

🎉 The Role

Your Core Responsibilities

This role is responsible to manage all aspects of Engineering Change/Product Design Change Implementation to the Maestro System in Manufacturing and in the Field. The Project Manager, Change Implementation Coordination, is part of the Operations team and works on complex change implementation tasks that require detailed analysis and evaluation of data to enable a smooth cut-in and roll-out of changes to the product. An essential part of the role is to ensure alignment across various parts of the organization and to drive projects from change initiation through change implementation.

Your Day-to-day Activities

Day-to-day activities include

• Acting as the interface between Operations, Supply Chain, R&D (including Sustaining/Continuing Engineering) and Customer Support organizations to coordinate the planning, roll-out and timely implementation of Product Design and Engineering changes.
• Developing and documenting the Change Implementation process in collaboration with related departments, including Quality functions.
• Driving and facilitating Change Coordination activities that are required during pre- and post-change implementation, including documentation and maintenance of records associated with the process. In addition, and as required: Establishing a cross-functional review meeting for Change Implementation Coordination, creating the agenda and facilitating the review and decision-making process.
• Analyzing existing processes for effectiveness and inefficiencies, and making improvements as needed.

How You’ll Fit In

The Project Manager, Change Implementation Coordination, is part of the Operations Team and reports to the COO Chief Operations Manager.

🧭 Qualifications, Skills & Attributes

In addition to bringing the required soft skills as a solution-oriented team player in a fast-paced start-up environment, this job requires solid experience in managing the implementation and the deployment of Engineering Changes/Product Changes to Manufacturing and Field/Service organizations. Must-haves for a successful contribution:

• Experience in Engineering Change implementation, including solid understanding of change implementation impact to Materials Planning, Manufacturing, Field/Service Customer-installed product and systems.
• Strong technical background
• Experience in the medical device industry (US FDA, international medical device regulations, ISO 13485 quality system requirements)
• Strong understanding of healthcare capital equipment
• Demonstrated Project Management experience
• New Product Introduction experience preferred
• Exceptional cross-functional collaboration, structured, effective and clear communication skills.
• Attention to detail and used to provide clearly structured documentation