Intuitive
medical device
RiskManagementEngineer3
Neural analysis suggests this role is
optimal for mid candidates.
“Risk Management Engineer 3 at Intuitive. Skills: Risk Management document support, quality advocacy, project management, Risk Analyses, update risk documentation, maintain tracing of risk to requirement to test, process risk documents, review of technical and quality information for regulatory submissions, Quality process improvement projects. Risk Management document support. quality advocacy”
What You'll Achieve.
drive reliability, quality, and safety to ever-better levels; build in product quality
Industry & Context.
solving tough engineering problems; Analyze deeply to ensure the solution is the most effective solution; Able to breakdown complex issues into simplified task; capable of identifying the critical issues from the trivial issues
Onsite, Travel not to exceed 10%
What They're Looking For.
Must Have
Able to navigate quality and compliance system with minimal oversight on individual projects, Basic knowledge of CFR 21 820/ ISO 13485 requirements for making process or design changes, Understand product risks, able to work with design and quality engineers to update risk documents, Understands Design Controls, Change Controls, Product, and Engineering Processes, Uses data to quantitatively communicate problem or issue, Basic functionality in PowerPoint, Understands typical Excel data analysis operations, Works with Peers to understand and document issues, Operates with minimal oversight for basic problems or assignments, and escalates appropriately for issues requiring clarification, Good writing and speaking skills in English
Nice to Have
1 to 3years of working experience in a medical device company, Experience with Agile/ACCS, TrackWise, or other electronic documentation systems, Participation in internal / external audits conducted, Aware of SPC & Six Sigma methodology and tools (e. g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram), Advanced degree
What You'll Do.
Risk Management document support
Participate in Risk Analyses for new and existing products
including review of both hardware and software
Using data from Post Market reviews
update risk documentation as needed
following confirmations with Project QEs and Design Engineering
Work with Design Engineering to maintain tracing of risk to requirement to test
Work with Manufacturing Engineering on process risk documents
Participate in review of technical and quality information for regulatory submissions
Participate in Quality process improvement projects (CAPA
Process NonConformance
other process improvements)
How You'll Work.
Team & Collaboration
Work with Design Engineering; Work with Manufacturing Engineering; Works with Peers to understand and document issues; Fully supports team decision, even if he/she disagrees with the decision; Gives credit to others for success, and does not blame others for his/her mistakes; Demonstrates constructive work relationship with others in the organization; Understands that the real success is the success of the whole team
Communication Scope
Good writing and speaking skills in English; Uses data to quantitatively communicate problem or issue
Process & Methodology
project management, Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues, Sets individual goals aligning with the team goal
Full Job 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. Primary Function of Position As Intuitive’s da Vinci® Surgical System and other medical devices become adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex ele
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