Staff Manufacturing Engineer, New Product Introduction
Intuitive · Sunnyvale, CA · smartrecruiters
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Job Description
Job Description
Primary Function of Position
The Staff NPI Manufacturing Engineer in Intuitive Surgical’s Future Forward group will support the development of manufacturing processes and equipment for endoscopes, instruments, and/or accessories for a new robotic surgical platform. As an early member of the team, this role will help define the eventual product from early prototypes through clinical trials and into product launch.
Essential Job Duties
As part of the team, the engineer will work with team members to:
- Assess manufacturability of current designs and identify critical steps for further process development
- Develop NPI strategy for supporting verification and validation of product
- Build and maintain top level assemblies in Agile document control system
- Define pilot manufacturing lines for system components, instruments, and accessories, order equipment, and bring up the line
- Design, specify, purchase, build, and qualify aids and test equipment for the line as necessary
- Manage completion of all manufacturing documentation in support of launch
- Support pilot line builds of product for early feasibility studies
Qualifications
Required Skills and Experience
- Minimum 6 years’ experience, at least 2 years in medical device manufacturing
- Ability to leverage internal and external resources to complete tasks
- Experience with validation/verification of processes, equipment, and products
- Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design
- Quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk
- Familiarity with mechanical CAD (Solidworks), ERP (SAP), PLM (Agile), and ALM (Polarion) software
- Strong organizational skills and proven ability to work on multiple fast-paced project threads simultaneously
- Clear and efficient documentation skills
Required Education and Training
- BS in relevant engineering discipline
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 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.
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.