
Design Control Process Leader
Intuitive Surgical is seeking a highly motivated and detail-oriented individual to join our team as a Design Control Process Leader. As a global leader in robotic-assisted minimally invasive surgery, our company is dedicated to revolutionizing healthcare through cutting-edge technology and innovation. This role is crucial in ensuring the design control process is effectively managed and compliant with regulatory requirements. We are looking for a driven individual with strong leadership skills and a passion for quality and process improvement. Join us in our mission to improve patient outcomes and make a meaningful impact in the field of healthcare.
- Manage and oversee the design control process to ensure compliance with regulatory requirements and company standards.
- Develop and implement strategies for continuous improvement of the design control process.
- Lead and mentor a team of design control specialists to ensure efficient and effective execution of projects.
- Collaborate with cross-functional teams to establish and maintain design control procedures and policies.
- Conduct regular audits and assessments to identify areas for improvement and ensure adherence to design control processes.
- Stay updated on industry trends and changes in regulatory requirements to ensure compliance.
- Work closely with product development teams to ensure design control activities are integrated into the product development process.
- Facilitate and lead design control training for employees to ensure understanding and compliance.
- Drive a culture of quality and process improvement within the organization.
- Collaborate with regulatory affairs and quality assurance teams to ensure proper documentation and submission of design control activities.
- Communicate effectively with internal and external stakeholders regarding design control processes and compliance.
- Manage and allocate resources effectively to meet project timelines and objectives.
- Identify and mitigate potential risks and issues related to design control processes.
- Provide regular updates and reports to management on the status of design control activities.
- Act as a subject matter expert on design control processes and provide guidance and support to cross-functional teams as needed.
Bachelor's Or Master's Degree In Engineering, Industrial Design, Or Related Field.
Minimum Of 5 Years Of Experience In A Leadership Role Within A Medical Device Company, Preferably In Design Control Or Product Development.
Strong Understanding Of Fda Regulations And Iso Standards Related To Medical Device Design And Development.
Excellent Project Management Skills, Able To Lead Cross-Functional Teams In A Fast-Paced And Dynamic Environment.
Experience With Design Control Tools And Methodologies, Such As Risk Management, Design Verification And Validation, And Design Reviews.
Risk Management
Quality Assurance
Process Improvement
Project Management
Change control
Design verification
Team Leadership
Regulatory compliance
Documentation management
Technical Expertise
Design Validation
Design Oversight
Communication
Conflict Resolution
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Design Control Process Leader in Sunnyvale, CA, USA is between $90,000 and $120,000 per year. This may vary depending on the specific industry, company size, and individual qualifications and experience. Salary may also be impacted by bonuses, benefits, and other factors.
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Intuitive Surgical Inc. is an American corporation that develops, manufactures and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System.

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