Process Manager, Production & Controls

Company Description

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

Primary Function of Position:

• Accountable for Quality Improvement Project (QIP) completion and ongoing sustainment and improvement of Production & Process Control processes and procedures to ensure scalability and effectiveness.
• Drive efforts to finalize the new process (in flight).
• Work with the Business Units (BU's) to develop the strategic roadmap for processes and procedures continuous improvement, head the development and implementation plan, secure resources, and complete projects.
• Define long-term accountabilities and serve as business manager for Production and process controls.
• Oversee updates of SOPs, Instructions, or business processes and associated training plans.
• Is the SME for Production and process control. Represent Intuitive during Internal and External Audits.
• Will be the owner of any associated audit findings in production and process control.
• Accountable for production and process control QMS processes.
• Heads up production and process control working team; guide a cross-BU team of stakeholders through influence.
• Has formal reporting responsibilities to Operations.
• Manage curriculum-based training program for production and process control.
• Evaluate and enhance the effectiveness of the training program to ensure that all affected teams have the necessary knowledge and skills to perform their work successfully.

Roles & Responsibilities:

• Continuously evaluate and optimize production and process control processes to enhance efficiency and effectiveness, especially as our business grows.
• Identify areas for improvement through process audits, feedback collection, and data analysis.
• Implement standardized work instructions and best practices to ensure consistent and streamlined execution across business units and global locations.
• Leverage automation tools and technologies to improve process efficiency and scalability.
• Foster a culture of continuous improvement by encouraging employee involvement and feedback in process enhancement initiatives.

Additional Accountabilities:

• Oversee QMS changes. Identify, maintain, and coordinate review and approval of changes.
• Review / Approve all production and process control QMS documents.
• Maintain the Approval Groups in Agile.
• Create a QMS roadmap that includes infrastructure needs (e.g., IT tools).
• Manage budget and headcount requests for these projects.
• Partner with other Process Owners to ensure effective QMS alignment and coordinate high-impact QMS changes across workstreams.
• Represent team in project team to implement system-level improvements.

Qualifications

• 12+ years of experience and a Bachelor’s degree; or 8+ years of experience and a Master’s degree; or equivalent experience
• 6+ years of experience in the medical device industry
• Experience leading multiple change management and transformation projects with effective rollout and training of new processes and procedures
• Experience in resolving audit findings and completing CAPAs
• Experienced in launching and maintaining medical device products
• Experience writing or executing process validation protocols
• Understanding IQ, OQ and P