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Design Control Process Leader

2 months ago

Sunnyvale, California, United States Intuitive Surgical Full time
Job Summary

We are seeking a highly experienced Design Control Process Leader to join our team at Intuitive Surgical. As a key member of our Quality team, you will be responsible for leading the development and implementation of Design Control processes and procedures to ensure scalability and effectiveness.

Key Responsibilities

Process Improvement and Scalability:

  • Continuously evaluate and optimize Design 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.

Compliance:

  • Serve as primary accountable person for Design Control and act as the representative during audits of Design Control.
  • Stay updated on relevant regulations and industry standards. Take proactive measures to ensure and improve our compliance with Design Control requirements.
  • Manage curriculum-based training program for Design 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.

Design Control Governance:

  • Head the Design Controls the Process Owner. Work with stakeholders from business units and relevant cross-functional partners.
  • Develop and maintain documentation outlining the governance structure, processes, and key performance indicators.
  • Develop a plan for the future state of the Design Control governance model. The process owner will also be accountable for this plan post implementation.
  • Manage a board representative of functional people (DE, SE, PQ, Reg, etc.).
  • Implement regular communication channels and meetings to ensure effective collaboration and agile decision-making.

Additional Accountabilities:

  • Oversee QMS changes. Identify, maintain, and coordinate review and approval of changes.
  • Review / Approve all Design 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.
  • Collaborate with other Design Control 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.
Requirements

Skill/Job Requirements:

  • Minimum BS in Engineering, Master's preferred
  • A minimum 15+ years' experience in the relevant subject matter.
  • A minimum 8+ years of medical device experience.
  • Has successfully led multiple change management and transformation projects with effective rollout and training of new processes and procedures.
  • Experience in resolving audit findings and completing CAPAs.
  • Have deep knowledge of medical device regulations.
  • Experienced in launching and maintaining medical device products.
  • 20% domestic/international travel needed.