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, design, and problem-solving skills to a dynamic team creating precision instruments for the daVinci SinglePort (SP) platform. This highly skilled manufacturing engineer will help with the roll out of a new MES (Manufacturing Execution System) system for SP Instruments and Accessories products and then 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 and existing products.

Essential Job Duties

• Support the roll out of a new MES (Manufacturing Execution System) system for SP Instruments and Accessories products:

• Update Bill of Materials and Manufacturing travelers

• Qualify equipment (IQOQPQ) that requires updating due to MES system transition

• Update other process documentation related to the new MES system as required.

• Be the subject matter expert for all the engineers in the SP Instruments and Accessories Process Engineering Organization on using the new system.

• Be the voice of manufacturing engineering in all system improvements.

• Support system level testing.

• Execute the task above for all Single Port Instrument and Accessories projects.

• After MES rollout, support Single Port Core Instruments Products

• Provide daily engineering support for existing in-house manufacturing lines for NPI product line and mature manufacturing lines

• Lead root cause investigations and drive dispositions and corrective actions for assembly-related defects using Product and Process FMEAs as guidance for various non conformances.

• 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 equipment and process qualification efforts (IQOQPQ and PPQs)

• Own and drive continuous improvement of product quality, throughput, and cost. Utilize objective data and statistical analysis to inform and drive decisions.

• Projects included Manufacturing Process Instruction updates, Test Method Validations, equipment and aid design, line balancing efforts, capacity improvement projects, etc; and the documentation required

• Develop, 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 Gage R&R.

• Specify and refine BOMs, workflows, and manufacturing travelers

• Revise manufacturing related risk documents including Process FMEAs, Manufacturing Line Specifications, and Equipment Specifications

• Support implementation of design improvements to existing products, including:

• Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA)

• Assist in Design Verification and Validation (V&V) builds

• Coordinate cut-in/implementation in production.

• Provide manufacturing feedback for supplier change requests (SCRs).

• Support the task/responsibilities above related to new product introductions.

Required Skills and Experience

• Strong 3D modeling/CAD experience (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, planners, buyers, clinical engineers, supplier engineers, and upper management.
• Able to travel periodically to suppliers or Intuitive manufacturing sites.

Required Education and Training

• Minimum B.S. Mechanical Engineering or related technical discipline.
• 5+ years with a B.S, or 3+ years, with an M.S of experience as a process or manufacturing engineer supporting products with significant mechanical content.

Working Conditions

• Ability to lift 50lbs a plus

Preferred 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.

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.

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.