At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.
As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.
We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.
Primary Function of Position:
Leads cross-functional project teams in the execution of regulatory integration projects from initiation to launch. Responsible for management of scope, gap assessments, deliverables, timeline, resources and overall project plan to meet project objectives.
Roles & Responsibilities:
- Integrates with the Regulatory Surveillance Management (RSM) process to assist in assessment and prioritization of new or changed requirements.
- Oversees and coordinates functional participation within the project team and contributions towards the project plan.
- Liaises with applicable product, engineering, quality, etc. Review Boards (e.g. xRBs) and/or supporting functions to identify resources, align support, and collect input for the assigned project(s).
- Facilitates detailed gap assessments with the cross functional team, as required, to determine scope and plans to integrate requirements.
- Leads project Core Team meetings to balance project scope, schedule and resources for overall success.
- Ensures clear Roles and Responsibilities for functional groups supporting the project.
- Manages the project plan by identifying critical path, constraints, contingencies and mitigations to achieve project objectives.
- Communicates project status and risks to stakeholders and executive sponsors.
- Manages project risks and escalates threats to project plan as required to functional management and senior leadership.
- Ensures Quality System processes are followed per relevant procedures by functional team members.
- Organizes and leads project review meetings and support Steering Committee or other management escalation meetings, as needed.
- Works across the organization to identify resources, align support, and collect input for the project.
- Provides feedback to team members regarding performance and requirements.
- Contributes to process optimization by sharing best practice development, lessons learned, resource leveling and process input.
Skills, Experience, Education, & Training:
- Minimum Bachelor’s degree or foreign equivalent in Regulatory, Engineering, Science, Business, Information Systems, Finance or related field and minimum 8+ years of project management related experience required. Master’s degree preferred.
Experience must include:
- Project Management experience;
- Experience in planning and leading a diverse, cross-functional team;
- Strong relationship building experience;
- Seeks, recognizes, and executes creative and simple solutions to resolve complex project challenges; routinely steadies the team when stressed; leads by example
- Previous experiences with medical devices in an FDA regulated environment;
- Solid understanding of global medical device regulations;
- Experience with Agile or similar Change Management software and Smartsheet and/or Microsoft Project.
- Experience with Clarity or other resource management tool
- Certification in project management (PMP) or proficient experience utilizing key Project Management methodologies, desired.
- Highly developed interpersonal skills, with strong ability to lead internal and external resources, and build commitments
- Demonstrated ability to communicate effectively (both written and verbal) with people at all levels, from individual contributor to executive leadership.
- Ability to work well in a fast paced, team environment, taking a leadership role, dealing with ambiguity effectively and ability to drive towards risk-based decisions.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift : Shift 1 - Day
Travel : Yes, 10 % of the Time
Travel Requirements: Yes, 10 % of the Time Shift: Shift 1 - Day