Project Manager

Duties:

Leads projects of very large size and/or high complexity, and/or multiple projects of mixed complexity levels and sizes.

May provide support to one or more projects of high complexity as part of a program or portfolio team.

Manages project with budget responsibility up to (USD)5 million, and may require matrix supervision of staff from other IT departments and divisions, and contractor/vendor resources.

Responsible for achieving project objectives and completion on time, on budget, and in conformance to Client enterprise, departmental, and IT methodologies and practices as required.

Solicits technological input from senior technical resources assigned to their project team(s), and facilitates technology problem-solving activities.

Works directly with institutional committees and oversight bodies to understand priorities, develop project action plans, facilitate approvals, and work across organizational boundaries to develop and/or implement project proposals that meet the objectives of those groups.

Supports strategic planning and execution of multi-year initiatives that may involve multiple inter-relationships and complexities, requiring the development and execution of complex communication and management plans to achieve.

Makes judgments and takes any reasonable action required to accomplish agreed to project objectives under general guidance.

Serves as subject matter expert regarding both departmental and institutional project management practices, methods and standards.

Leads the ongoing adoption and continued evolution of a Project Focused Culture within the Information Technology department.

Manages multiple competing objectives and communicates complex technical information in clear and unambiguous terms to management and end user personnel.

Strictly adheres to budget management and guidelines of both the Information Technology department and the institution.

Performs additional job-related functions as detailed by immediate supervisor.

Skills:

We are seeking a Senior Project Manager to help lead projects in the Software as Medical Device (SAMD) & Regulatory group within the Center for Digital Health at Client.

Please note the very specific project management experience we are seeking for this role:

5+ years of experience of demonstrated project / technical program management / systems engineering experience with complex medical device R&D.

Complete understanding and experience with regulated product development life cycle from concept to launch.

Working knowledge of FDA Quality regulations related to medical device development and quality and regulatory standards 21 CFR 820, ISO 13485, 14971, 62304, 62366.

Understanding of medical device DHF, DMR, and medical device regulatory submission deliverables.

Identify stakeholders, understand needs of the customer, and facilitate early identification of potential safety risks for a variety of AI/ML software as medical device products.

Experience educating and guiding novice teams through the regulated medical development lifecycle.

Well-versed in cross-functional communications through development activities (Planning, Design Inputs/Outputs, Design Verification/Validation, Design Transfer).

Education:

Bachelor s Degree and a minimum of 10 years experience managing projects ranging from simple to difficult complexity while demonstrating increasing scope and depth of responsibilities, and involving multiple technological environments and/or business areas that IT supports, with demonstrated competency in the application of PMI Process Groups and Knowledge Areas OR Master s Degree with a minimum of 7 years experience managing projects involving Information Technology and/or Healthcare disciplines, ranging from simple to difficult complexity while demonstrating increasing scope and depth of responsibilities, and involving multiple technological environments and/or business areas that IT supports, with demonstrated competency in the application of the PMI Process Groups and Knowledge Areas.

Licensure/Certification Required:

Possession of current Project Management Professional (PMP) certification, or a comparable current certification from a nationally-recognized project management governance body.

This certification must be obtained within three (3) years of date of hire.

Required

Artificial Intelligence