Senior Project Manager (Medical Device Documentation)

Job Description

The Project Manager III creates and manages project schedules to support the development of technical documentation / instructions for use (IFU) for medical devices and user manuals for non-medical devices. The Project Manager III works with technical writers and localization specialists using engineering change order system to set up new part numbers, develop change requests, and route technical documentations for approval.

Roles & Responsibilities :

Work with technical writers, localization specialists, project management office, and core teams to outline the scope of the user documentation and localization projects.

Work with technical publications team to identify all affected user documentation to be created or updated.

Create project schedules for technical documentation deliverables.

Work cross-functionally with internal teams including Regulatory, Quality, Engineering, Clinical Development, Human Factors, Product Marketing, and Training to gather IFU requirements and create strategy and timeline to support project and / or business needs.

Identify, communicate, and help resolve project risks, resource overloads, and content creation or revision constraints.

Represent technical publications function on project core teams.

Work with marketing commercialization team on international project roll-out schedules.

Coordinate with technical publications management on resource needs and project timelines.

Establish deadlines and support needs with external translation and print vendors.

Understand regulatory requirements for labeling and documentation. Work with regulatory on submission, country-specific registration strategy and timelines.

Ensure Design Control processes are followed per relevant procedures.

Participate in and initiate department process improvement projects.

Create language kits and / or strategize on user documentation architecture and work with procurement for fulfillment, when needed.

Conducts or delegates first article inspections, when needed.

Flexible to support various other duties and assignments as requested to assist the overall function of the department.

Experience, Education, & Skills :

Minimum 1-4 years of project management preferred.

Minimum Bachelor’s degree in related field or equivalent work experience preferred.

Project Management Institute (PMI) PMP certification preferred.

Strong communication and presentation skills required.

Strong interpersonal skills and ability to interact with core team leaders and other functions required.

Strong organizational skills and ability to manage deliverables for multiple projects under tight deadlines, set priorities, and manage time effectively

Creation of project schedules using MS Project, Smartsheet or similar software required.

Extensive knowledge of project management processes, organizational change management concepts, and business process improvement and documentation methods required

Excellent written and verbal communication skills required.

Ability to multi-task and work both in a team and independently required.

Experience with Change Management software (Agile or equivalent) highly preferred.

Previous experience with medical devices in an FDA and internationally regulated environment highly preferred.

Highly organized with good analytical skills preferred.

Understanding of localization process preferred Due to the nature of our business and the role, please note that Intuitive and / or your customer(s) may require that you show current proof of vaccination against certain.