NPI Manufacturing Engineer

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 and equipment design skills to a dynamic development team developing sensing platforms for minimally invasive robotic surgery. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical instruments. Essential Job Duties Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions Experience developing manufacturing lines - building prototype parts, training operators, identifying fixtures/tooling needed and conducting process validation Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment Define and document PMC processes for newly introduced fixtures and tools Analyze manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing Responsible for the validation and qualification of manufacturing equipment and processes to production status leveraging standard qualification approaches (IQ/OQ/PQ) Provide production support of sustaining and startup manufacturing lines as needed Conduct testing of software releases before deploying on manufacturing line 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 of new products. Maintains connections with leading manufacturing equipment suppliers and is aware of latest state of the art processes and equipment Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans Maintain compliance with medical device quality system including corrective action closure and Change Order implementation Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress Provide resource planning and budget estimates for product and process improvements, tooling development, and testing Required Skills and Experience Prior experience with managing product and process changes. Diligent organizational skills and proven ability to simultaneously work on several fast-paced projects. Must have experience releasing new product or manufacturing line through design/build process to production. Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams. Proven technical, analytical, and troubleshooting skills. Required Education and Training Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience. Minimum 4 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content. Working Conditions None Preferred Skills and Experience Meets at least five of the following criteria: Demonstrated successful transfer of complex manual processes to more automated processes. Prior responsibility for process, equipment, or product validation/verification Mechanical CAD software experience (SolidWorks or equivalent) Programming experience (LabVIEW Preferred) Experience with Lean Manufacturing/Six Sigma principles Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment Prior experience with complex device manufacturing Previous experience with ERP systems (preferred SAP) Experience with line duplication and/or transfer 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 Admin