Manufacturing Engineer, Stapler Reloads

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Primary Function of the Position    Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision stapling products for minimally invasive robotic surgery. The role requires active participation in the sustaining manufacturing engineering organization to refine mechanical components, assemblies, process documentation, tooling/fixtures/test tools, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic stapling products.  Essential Job Duties   Hands-on manufacturing sustaining support, setting up new manufacturing lines, duplication of manufacturing lines. Provide production line support for day-to-day engineering issues on manufacturing lines.  Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).  Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.  Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability   Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.  Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns.  Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions.  Create, maintain, and improve manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.  Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment.  Analyze manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.  Ability to travel to international sites, including Mexico and Malaysia. Required Skills and Experience    Bachelors’ degree in Mechanical Engineering, related technical discipline, or related work experience. High mechanical aptitude.  Strong oral and written communication skills.  Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments, GR&R) in data analysis for process development and problem-solving.  CAD experience (preferred SolidWorks).  Able to travel periodically to suppliers or Intuitive manufacturing sites.  Required Education and Training    Bachelor's degree in an engineering discipline with 2+ years of relevant experience, or equivalent practical experience. Working Conditions   Ability to lift 25 lbF Preferred Skills and Experience    Prior experience working with complex mechanism manufacturing equipment Prior experience with manufacturing packaging equipment Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment.  Skills in problem solving and using SolidWorks, Minitab, Python, SQL, Tableau and/or other SW tools for data analysis to identify root cause and drive corrective actions.  Use of Agile or similar lifecycle management system tool.  Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).   For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requireme