Sr NPI Manufacturing Engineer

Primary Function of Position We are seeking a collaborative and technically strong Manufacturing Process Engineer to support next-generation needles and accessories for advanced bronchoscopic instruments. In this role, you will lead the development, validation, and continuous improvement of manufacturing processes for precision flexible needles, catheters, and single-use accessory assemblies. You will partner closely with Design Engineering, Materials Engineering, Quality, and Supplier teams to ensure robust, scalable processes that deliver exceptional product performance and patient safety. Essential Job Duties Develop, release, and validate scalable manufacturing processes for next-generation, single-use and multi-use accessory assemblies. Support development of joining and forming processes such as laser welding, adhesive bonding, tipping, grinding, crimping, swaging, polymer reflow, and more. Define robust assembly and inspection methods for precision needle, catheter, and small-bore tubing subassemblies. Ensure high-quality build and test practices, including tensile, pull, puncture, and dimensional testing, as well as packaging and sterilization compatibility. Perform statistical analysis including Cpk, process capability analysis, DOE, ANOVA, regression analysis Monitor yield trends and implement corrective actions to improve manufacturability and reliability. Create and maintain pFMEAs and mitigate identified risks. Collaborate with automation, equipment, and test engineering to improve automated test coverage and data traceability. Partner with: Mechanical and Materials Design Engineers on DFM/DFX reviews Clinical and Human Factors teams to understand needle and accessory performance and usability needs Supplier Engineering on tubing, extrusions, machined, molded, and packaging components Support early NPI ramp to launch Provide hands-on support to the production line during issue resolution and scale-up. Lead root cause investigations involving needles and accessories. Implement yield and cycle time improvements in needle and accessory assembly processes. Develop and revise detailed manufacturing process instructions for processes. Train technicians and manufacturing staff in new processes and quality standards. Required Skills and Experience Minimum of 8 years or Master's plus 6 years in manufacturing engineering, preferably in medical device, catheter, needle, or single-use disposable manufacturing environments Experience with precision mechanical assemblies, polymer processing, and joining processes (e.g., laser welding, bonding, reflow). Working knowledge of Six Sigma tools, Cpk, DOE, statistical process control Root cause analysis experience (8D, Fishbone, DMAIC) Familiarity with ALM/PLM systems for ECO and risk management Basic coding proficiency in Python for data analysis or automation Strong communication skills across technical and non-technical teams Ability to manage multiple projects in a fast-paced NPI environment Willingness to travel occasionally to suppliers or manufacturing sites Required Education and Training BS in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or related field Preferred Skills and Experience Experience in medical device manufacturing (ISO 13485) Familiarity with ISO 9001 and regulated product development environments Hands-on experience with catheter, needle, or minimally invasive device assemblies, including packaging and sterilization validation Experience with Agile and SAP systems or equivalent Demonstrated success in experimental design and structured problem solving Experience in Controlled Environment Rooms (CER) 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 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. Accommodation & Accessibility Notice: Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com. 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.