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Project Coordinator

Coordinate and track all product development activities for regulatory compliance
Mexicali, Baja California, Mexico
Senior
yesterday
Intuitive

Intuitive

A global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery.

Project Coordinator

At Intuitive, we are united behind our mission: 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. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.

Job Description

We are seeking a Senior Project Coordinator to support the Program Management team focused on new product development. The Senior Project Coordinator will help execute product development and process-specified activities to ensure compliance with established Design Control and Project Management processes, with a strong focus on collaboration with cross-functional groups. Need to be proactive, a strong communicator, key influencer, relationship builder, detail-oriented, and have investigative skills. This is the position for you if you love to help teams thrive and exceed expectations!

Job Requirements:

  • Work with Project Managers defining and tracking Project Plans, Risk Management Plans, work breakdown structure, project budget, and task definitions
  • Monitor and report project status for project milestones, documentation, and deliverables
  • Review projects for possible interference/variances to schedule and/or specifications: proactively organize efforts to alleviate bottlenecks and speed execution.
  • Coordinate and follow up on activities of team leader / program manager; represent the team and assigned projects where necessary
  • Support/Lead team meetings including taking minutes and tracking action items.
  • Initiate, develop and implement departmental, process related improvements
  • Closely track Verification and Validation protocols and reports for Regulatory submissions
  • Work all across New Product Development on milestone activities including ECO submissions, reviews, and closure
  • Coordinate design reviews and phase gate reviews– Assembling presentations, Checklists, action items, etc.
  • Solid understanding of Quality Systems or Design Controls for Medical Devices
  • Setup Design History File (DHF) structure; work with project team to make sure document owners update documentation and save to DHFs
  • Maintain business review packages and business records for projects assigned
  • Strong collaboration and direct participation with Regulatory during final preparations for submissions
  • Track Issues, coordinate last minute changes
  • Liaison with Document Control and follow-up with approvers of change orders to ensure timely review and approval
  • Manage lab resources (hardware, software, instruments and accessories) and monitor allocations based on the needs and schedule of various competing projects.
  • Support historical investigations including audit requests, CAPA, and process improvement projects
  • CAPA tracking/closure support

Qualifications

Skills, Experience, Education, & Training:

  • Bachelor's Degree required. Masters degree preferred.
  • 5+ years of directly related experience desired, medical devices experience strongly preferred
  • Additional specialized training in a discipline such as computers and/or planning and scheduling
  • Good organizational and investigative skills
  • Proactive problem solver
  • Excellent verbal and written communication skills
  • Ability to switch between many different projects quickly
  • Passion for rapidly executing projects creating robust and reliable products
  • Familiar with waterfall, SCRUM, and hybrid project management techniques
  • Should be highly proficient in Word, Excel, and PowerPoint
  • Active user of Microsoft Project or other project planning and tracking tools
  • Proficiency in Oracle/Agile and SAP a plus

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

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Project Coordinator
Mexicali, Baja California, Mexico
Customer Success
About Intuitive
A global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery.