Project Director
Job Overview:
We are seeking an experienced Project Director to lead our technical projects through a matrix of cross-functional groups.
As a key member of our team, you will be responsible for project planning and management, ensuring project results meet requirements regarding technical quality, reliability, schedule, and cost.
* Develop and implement mechanisms for monitoring project progress and intervention/problem-solving throughout the project lifecycle.
* Provide timely and accurate information and status updates to project sponsors, end-users, and management.
* Manage multiple, often concurrent projects and consistently meet expectations.
* Maintain a clear focus on life cycle costs and ensure that scope, schedule, cost, and customer expectations are met.
Requirements:
Key Qualifications:
* A minimum of 4 years' experience and a proven track record in project management, preferably in the medical device sector.
* Strong understanding of medical device regulations, including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits, and international environmental regulations.
* Experience in development of 510K/PMA regulated products required.
* Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals.