Intuitive Surgical Careers
Design Engineering Label Specialist
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 181797
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
If you want to use your Product Lifecycle Management (PLM), label design, and requirements/qualification systems skills to create technical documents about a product that really matters, as in a life changing and life-enhancing innovation, then this is your opportunity. We are the company behind the da Vinci® Surgical Systems. This elegant, robotic assist tour de force enables skilled surgeons to provide a precise, minimally invasive alternative to open (large incision) surgery. This is the first and only surgical system approved by the FDA for soft tissue surgery. Our surgical systems have touched the lives of more than 3 million people worldwide.
Why this Opportunity?
Want to actually touch the products you will create compliant labeling for and directly work with the engineers who are developing our next innovation? Want to influence labeling standards? Want to help implement improved tools and processes? Love mechanical products, robotics, or medical devices? Then this may be the opportunity for you.
In this role, you will have the opportunity to be part of a growing and changing technical publications and global labeling department. You will be part of the influence over standards, guidelines, publication/labeling strategies, and documentation process improvements. Your voice will matter and your expertise will be appreciated.
We’re looking for a Design Engineering Label Specialist who is passionate about helping create traceable, compliant, and standardized labels for sustaining and new product teams. Having a great eye for layout, a mechanical mind, and the ability to work as part of a group, will be of great value. Knowing technical illustration is helpful and product lifecycle/label design/configuration management/enterprise resource systems knowledge is even better. If you have created in-depth processes and labels for medical devices or mechanical products, you may be a great fit for this role.
Translate requirements, attributes, and UDI/GTIN structure into labels for medical device robotic assistance systems and instruments. Manage qualification protocols, reports, and trace requirements for closure of labeling projects. Work with engineers to develop appropriate labels and content that is easy to roll out to manufacturing and complaint to all FDA and regional regulatory guidelines.
Roles and Responsibilities:
• Work with subject matter experts (SMEs) to research and develop content for system and instrument labels• Design and edit printed and laser marked labels using integrated label design system• Conduct qualification and verification of attributes, images, and translation tables• Own operating procedure and work instruction updates• Work with regulatory experts on US FDA and regional regulatory agency submission deadlines and requirements• Complete documentation control steps to release final labels. This includes Engineering Change Order (ECO) work inside the change control system.• Collaborate with department team members and with engineering, training, service, legal, and others to develop label content
• 2-4 years PLM, New Product Introduction (NPI), label design software, or configuration management experience required• Bachelor’s degree in engineering, scientific discipline, or equivalent preferred• Excellent collaboration and communication skills required• Understanding of mechanical concepts and complex robotic mechanical devices preferred• Previous experiences with medical devices and an FDA regulated environment preferred• Project management experience preferred
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.