Manufacturing Mechanical Engineer

Intuitive; Sunnyvale (CA); On-site; USD 116,000 - 136,000; Full time

Job summary

Intuitive is seeking a Manufacturing Engineer to join our dynamic team in Sunnyvale, contributing to the design and optimization of high-volume assembly lines for minimally invasive robotic instruments. You will refine BOMs, manufacturing plans and work instructions while improving fixture tooling and equipment performance.

The role requires hands-on validation of equipment, PFMEA risk assessment, and adherence to medical device quality systems.

Qualifications

• BS / MS degree in Engineering or equivalent work experience.
• 3+ years experience as design or manufacturing engineer supporting product with significant mechanical/electromechanical content.
• Strong communication, analytical and troubleshooting skills.

Responsibilities

• Create, maintain and improve high-volume manufacturing assembly lines, BOMs, workflows, manufacturing plan and work instructions.
• Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
• Independently analyze trends for equipment performance.
• Analyze instrument-manufacturing line from a PFMEA risk perspective and validate tests.
• Validate and qualify manufacturing equipment and processes (IQ/OQ/DQ/PQ).
• Provide production line support for day-to-day engineering issues on core instrument lines.
• Identify and implement continuous improvement projects for yield, cycle time, reliability and cost.
• Provide DFx input to enhance manufacturability of core instruments.
• Maintain compliance with medical device quality system including CAPA, dispositions and ECO implementation.
• Provide failure analysis support for discrepant production components, assemblies and field returns.
• Travel periodically to suppliers or Intuitive Mexicali plant.

Skills

Communication

Analytical thinking

Troubleshooting

Change management

Technical writing

Education

BS / MS in Engineering

Tools

CAD (SolidWorks)

Job description

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Min. Salary Region 1: 136100 USD
• Global Job Level (HCM): Professional 3 (9)
• Min. Salary Region 2: 115700 USD

Company Description

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.

Job Description

Primary Function of Position

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in manufacturing engineering organization in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.

• Create, maintain and improve “high-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
• Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
• Independently and proactively determines and analyzes trends for equipment performance
• Analyze instrument-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 leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• Provide production line support for day-to-day engineering issues on core instrument lines i.e. resolve emergency and unscheduled problems/repairs of equipment.
• 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 core instruments.
• Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
• Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
• Able to travel periodically to suppliers or Intuitive Mexicali plant

Qualifications

Required Skills and Experience

• Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
• Strong technical analytical and troubleshooting skills.
• Prior experience with managing product and process changes.
• Strong organizational skills and proven ability to work on fast-paced projects simultaneously.
• Prior experience with technical writing.

Required Education and Training

• BS / MS degree in Engineering discipline or equivalent work experience.
• 3+ years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.

Preferred Skills and Experience

• Prior responsibility for process, equipment or product validation/verification.
• Prior experience designing automated equipment, complex mechanism manufacturing is a plus
• CAD experience (preferred Solidworks).
• Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, testing of optical devices, and fiber routing is preferred
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus

Additional Information

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.

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 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.

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