Sr NPI Manufacturing Engineer

Company DescriptionIt 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.Job DescriptionPrimary Function of the PositionContribute your technical manufacturing, design, and problem-solving skills to a dynamic team creating precision instruments for the daVinci SinglePort (SP) platform. This highly skilled manufacturing engineer will support manufacturing lines for both mature and new products. Responsibilities include providing daily support for existing manufacturing lines, continuous improvement efforts, as well as developing manufacturing equipment and assembly processes for new products.Essential Job Duties Sustain and improve existing manufacturing lines:Provide daily engineering support for existing in-house manufacturing lines.Own and drive continuous improvement of mechanical fixtures and processes to improve product quality, throughput, and cost. Utilize objective data and statistical analysis to inform and drive decisions.Lead root cause investigations and drive dispositions for assembly-related defects using Product and Process FMEAs as guidance.Support quality system compliance including ECO review and implementation, discrepant material dispositions, nonconformance evaluations, and quality notifications.Troubleshoot, resolve, and document equipment and process malfunctions in compliance with GXP and Intuitive Quality System requirements.Assist in line transfer and line duplication activities.Support implementation of design improvements to existing products, including:Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA)Lead Design Verification and Validation (V&V) buildsCoordinate cut-in/implementation in production.Provide manufacturing feedback for supplier change requests (SCRs).Support equipment and process qualification efforts (IQOQPQ and PPQs)Contribute to the development of efficient manufacturing lines for New Product Introduction for medical devices for the daVinci SinglePort platform:Design and implement assembly/test fixtures to increase repeatability of complex assembly operations including cable routing, plastics joining (e.g. ultrasonic welding, heat staking, snap fit, press fit), metals joining (e.g. laser welding, riveting, swaging, crimping), and general assemblyDevelop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Test method validation.Specify and refine BOMs, workflows/travelers, and detailed work instructions.Collaborate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to meet project objectives including Design Verification & Validation and product launch. Examples include building prototype assemblies, training operators, identifying fixtures/tooling needed and conducting process validation.Create and revise manufacturing-related risk documents including Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.Leadership Responsibilities:Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining continuity of material supply.Mentors and sets project tasks for Manufacturing Engineers on their specific project team, and on other teams as needed, to further company expertise & effectiveness.Establish milestones, support, and success criteria for responsible projects. Drive decisions and escalate key issues quickly maintaining stakeholder alignment.Keep the organization’s vision and values at the forefront of decision-making and action.QualificationsRequired Skills and Experience Strong 3D modeling/CAD experience designing complex mechanical fixtures and equipment (SolidWorks preferred)Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments) in data analysis for process development and problem-solving.Effective communication skills (verbal, written, and presentation) and comfortable interacting with production technicians, product design engineers, planning, buyers, clinical engineers, and suppliers.Able to travel periodically to suppliers or Intuitive manufacturing sites.Required Education and Training Minimum B.S. Mechanical Engineering or related technical discipline. M.S. preferred.8+ years with a B.S or 6+ years with an M.S of experience as a process or manufacturing engineer supporting products with significant mechanical content.Working ConditionsAbhility to lift, maneuver, and troubleshoot fixtures and toolsPreferred Skills and Experience Experience in mid-volume manufacturing of single-use devices or complex electro-mechanical assemblies is a plus.Experience in medical device design controls and manufacturing (ISO 13485) is a plus.Machine tool experience is a plus.Additional InformationDue 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 NoticesU.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 employeeswho 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’sstart 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 requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.SummaryType: Full-timeFunction: ManufacturingExperience level: AssociateIndustry: Medical Device