NPI Manufacturing Engineer

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 103,000 - 139,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking an NPI Manufacturing Engineer (Finance) to drive next generation product and process development for Ion Accessories.

You will develop and release manufacturing processes, validate equipment, and ensure quality through data-driven improvements in a fast-paced medical device environment. Collaborating with design, clinical, quality and regulatory teams, you will implement DFx methods, create work instructions, and train manufacturing staff while traveling to

Qualifications

• Develop and release manufacturing processes and EFTs for new accessories.
• Ensure processes meet quality standards and analyze data for CPk and process capability.
• Conduct EFT qualifications for production readiness.
• Create and revise work instructions and train manufacturing staff.

Responsibilities

• Collaborate with design and clinical engineers to meet user needs.
• Coordinate with quality and regulatory teams to ensure compliance.
• Resolve failures and drive yield improvements.
• Support product design reviews with a focus on DFX.

Skills

Six-Sigma

CPk

Root cause analysis

Manufacturing process development

Data analysis

Team collaboration

Education

BS in Mechanical or Biomedical Engineering

Tools

CPk analysis tools

Quality systems

DFX methods

Job description

NPI Manufacturing Engineer (Finance)

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 skills in the areas of manufacturing process technologies, process development, early engagement with NPD, problem-solving, training, and project management in a growing medical device company. In this key role, you will be the driving force behind next generation product and process development within Ion Accessories.

Essential Job Duties

• Assist in developing and releasing manufacturing processes and EFTs for new accessories.
• Ensure processes meet quality standards. Manage and examine data for CPK and process capability, and implement improvements based on data.
• Conduct EFT qualifications to ensure readiness for production, validate equipment performance and reliability.
• Develop and validate test methods (TMV) to ensure product quality and compliance. Document and report validation results.
• Work closely with design engineers and clinical engineers to understand user needs and clinical requirements.
• Coordinate with quality and regulatory teams to ensure compliance with industry standards and regulations and support Supplier Engineering, Purchasing, Planning and Quality teams to resolve line facing issues.
• Resolve failures of varying complexity, of both process and hardware nature. Identify specific root cause and implement solutions to improve yield/manufacturability.
• Assist in product design reviews with a focus on DFX methods.
• Create and revise work instructions for assembly and test processes, and train manufacturing team on new content.

Required Skills and Experience

• Exceptional communication skills, both written and verbal. Necessary to engage with technicians, production management, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.
• A continuous improvement mindset
• Basic knowledge of process controls, including Six-Sigma, CPk, etc.
• Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
• Able to travel periodically to suppliers or Intuitive manufacturing sites.
• Exceptional organizational skills and proven ability to work on fast-paced projects simultaneously.

Qualifications

Required Education and Training

• Minimum BS degree in Mechanical or Biomedical Engineering

Working Conditions

• none

Preferred Skills and Experience

• Excellent problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments
• Excellent technical skills in prototyping, tooling development, and troubleshooting
• Demonstrated ability to effectively design experiments, solve problems and implement them in manufacturing

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.

Equal Opportunity Employer

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
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.

Base Compensation Range Region 1: $102,900 USD - $139,200 USD
Base Compensation Range Region 2: $87,500 USD - $118,300 USD
Shift: Day
Workplace Type: Onsite - This job is fully onsite.