Process engineer Jobs in Sunnyvale, CA

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

Job Description

Primary Function of Position:

Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.

The ideal Candidate possesses broad and deep hands-on metal injection molding (MIM), metal machining manufacturing and/or plastic injection molding experience along with skills to select and develop suppliers.

Roles & Responsibilities:

· Complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis

· Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation

· Select the right process and supplier for the part, considering long term fit and total cost of ownership

· Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations

· Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process

· Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation

· Effectively prioritize and advance multiple concurrent projects and tasks

· Clearly communicate project status to key stakeholders

· Build, own, and relentlessly pursue a vision for developing suppliers

· Understand proper level of documentation detail for tracking of actions and justification of decisions

· Generate key metrics for the team and suppliers, and continually drive for timely achievement of those metrics

· Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously

· Implement corrective and preventive actions for supplier process by driving supplier’s investigations and root cause analysis

· Provide effective and timely supply base health information and recommendation to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance

· Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation

· Work with suppliers and ISI engineering for the new product introduction to:

◦ Create product supplier landscapes to determine launch readiness and report to management

◦ Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.

◦ DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production

◦ Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers

· Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications

· Evaluate corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence

· Other reasonable duties

Qualifications

Qualifications

Skills, Experience, Education, & Training:

• Minimum Education: BS degree in Mechanical or Biomedical Engineering or equivalent experience, advanced degree preferred

• Minimum 6 years related experience in engineering and manufacturing of metal injection molding (MIM), machined metal or plastic injection molding parts. Metal injection molding experience is highly desirable

• Excellent written and verbal communication skills including presentations to executive level management

• Excellent Interpersonal skills and team building skills

• A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers

• Excellent Project Management skills

• Excellent analytical and problem solving skills along with good judgment

• Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities

• Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)

• Excellent knowledge of 21 CFR part 820 and ISO 13485

• Significant computer experience using Windows, Word, Excel, Project, Access, and ERP Information Systems, preferably SAP or Agile

• CAD experience with 3D modeling tools is a plus

• Experience with statistical analysis software such as Minitab is a plus

• Proven ability to motivate suppliers

• Experience in a high-volume medical device company is a plus

• Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information

• Ability to travel to suppliers on an as needed basis – domestic and international (approx 25%)

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.

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.

Base Salary Range Region 1:$160,600 - $231,000
Base Salary Range Region 2: $136,500 - $196,400
Shift: Day
Travel: 25% of the time
Workplace Type: Onsite - This job is fully onsite.