NPI Manufacturing Engineer

Primary Scope of Position:

This New Product Introduction Manufacturing Engineer (NPI Engineer) position reports to the Manufacturing Engineering Manager for Da Vinci Single Port Surgical System’s Instrument products. In this position, the NPI Engineer utilizes their knowledge to assist with the implementation of new assembly and test equipment along with assembly process improvements. Their primary focus is to develop assembly and test processes, confirm engineering requirements, consider process risks, and identify solutions to guide development. They focus on opportunities for poka-yoke, DfX, semi-automated and automated solutions, and design for assembly opportunities, specifically with an emphasis on safety, reliability, serviceability, manufacturability, and cost. In addition to process improvements, they also help respond to, escalate, and resolve emergent issues on the manufacturing line.

Roles and Responsibilities:

Technical Expertise

• Competency in mechanical, electrical, materials, and software engineering fundamentals with preferred experience in engineering design and manufacturing.
• Knowledge of equipment and methods to develop and implement assembly and test processes of complex medical devices.
• Ability to work with support teams on software, algorithms, electronic aspects of the device, and human interface needs.
• Assists with identification of opportunities to enhance manufacturability and product cost (DfX) and provides input to Product Development Engineering.
• Assists with the identification and assessment of potential process risks and mitigations and provides input to the development of process FMEA and other quality records.
• Assists with validation, qualification, and documentation of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).
• Provides technical support for failure analysis of discrepant production components, assemblies, and field returns. Collaborates with a cross-functional team to identify root cause, determine mitigations, and drive implementation using tools such as 8D, DMAIC, 5-Why, Fishbones, etc.

Skill/Job Requirements:

This role requires active participation to create and refine electro-mechanical components, mechanical assemblies, process documentation, tooling and test methods for robotic surgical instruments. The emphasis is on the mechanical design of manufacturing processes and assembly equipment. The successful candidate will have achieved the following:

• BS Mechanical, Biomedical, or Manufacturing Engineering. MSME, MSBMED, or MSMfgE and experience is as a design or manufacturing engineer preferred.
• Project participation and strong communication skills to drive assembly equipment, fixturing, and tooling design from development through implementation.
• Solid modeling/CAD experience (SolidWorks preferred).
• An introductory understanding of manufacturing processes including injection molding, machining, stamping, laser welding, design of experiments, and capability analysis.
• An introductory knowledge of Minitab, Excel, or other statistical analysis software and methods.
• Skills in prototyping, tooling development, process engineering, and troubleshooting.
• Comfortable interacting with engineers, management, technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
• Independent problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
• Proficient organization, follow-up, and documentation skills.
• References who will validate you as a team player, self-starter, and possessing a can-do attitude!

Highly preferred skills & experience:

• Manual assembly manufacturing process development experience.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
• Experience implementing changes to new or established products preferred.
• Machine tool experience a plus.
• Medical device experience preferred but not required.

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.