Quality Engineer 3

As Intuitives da Vinci Surgical System becomes adopted by an increasing population of hospitals surgeons and patients we are building a focused team to drive reliability quality and safety to everbetter levels. This focus applies to product in use product in manufacturing and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your handson experience in solving tough engineering problems your fascination with complex electromechanical devices and your passion for the best practices to design monitor and improve product and process.

Intuitive seeks a strong technical contributor who can help define practical useful quality metrics and specifications identify key opportunities for product improvement launch quality initiatives lead projects to implement these initiatives and serve as an expert consultant to help solve the most technically challenging quality problems.

The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization. You will not abide process red tape instead passionately seek the most efficient way to build in product quality. And you will also coach mentor teach and influence the engineering staff in best quality practices data analysis protocol development and design for quality and reliability methods.

Roles & Responsibilities:

In general Quality Engineering is a stakeholder and shares responsibility for:

• • Setting datadriven priorities for continuous improvement and ensuring quality/reliability/safety is built into Intuitives product design & manufacturing by partnering with Design Engineering Manufacturing Engineering and Supplier Quality.
  • Ensuring data quality process quality for anything that affects Intuitives product or patient outcome including the improvement of SOPs DOPs etc.
  • Supporting deep technical failure analysis root cause analysis resolution correction and prevention for challenging quality issues.
  • Generating risk assessments for product in the field including recall assessment by collaborating with compliance teams.

The main responsibilities for the individual sought by SP Product Quality are as follows. These responsibilities are aimed at ensuring effective product introduction and production support maintaining high quality standards and fostering continuous improvement within the organization.

New Product Introduction and Production Support:

• • Partner with manufacturing and supplier teams to effectively transfer products and processes into the production environment and provide ongoing support for these products.
  • Conduct production facility validation planning execution and documentation including Minimum Viable Product/Release (MVP/MVR) in Sunnyvale CA and assist in production transfer activities to other sites as needed.
  • Provide support for product manufacturing processes including failure analysis documentation review and approval tooling qualification and defect containment.
  • Offer quality engineering support for productrelated issues arising from manufacturing and suppliers manage containment assess risks and product impacts determine dispositions and make escalation decisions when necessary.
  • Analyze product failures and nonconformances drive product and process improvement opportunities conduct failure investigations review engineering assessments and support projects addressing these failures.
  • Plan and direct the creation of quality standards control and assurance procedures sampling plans test methods fixtures and processes for finished devices utilizing clinical and engineering knowledge.
  • Provide expertise in change assessments (product and process) and guide other quality engineers on process validations statistics riskbased sampling and measurement system analysis.

Leadership & Continuous Improvement:

• • Lead and represent Product Quality at monthly and quarterly review meetings focusing on Quality Data and Operations Review.
  • Identify present propose and drive continuous improvement initiatives by conducting trend analysis on reported manufacturing quality notifications and postmarket complaints and collaborate with engineering partners.
  • Assist in performing escalation assessments and driving necessary corrective and preventive actions (PIRs CAPAs etc.).
  • Support internal and external audits including preparation and direct interaction with auditors.
  • Plan and direct the creation of quality standards quality control and assurance procedures sampling plans test methods fixtures and processes for finished devices utilizing clinical and engineering knowledge.

Qualifications :

Skills Experience Education & Training:

• Good understanding of medical device company manufacturing operations and riskbased approaches to quality
• Minimum Education: Bachelors degree in electrical mechanical or system engineering math or physics. Advanced degree preferred.
• Minimum 5 years of working experience in Quality Engineering or in manufacturing environment; minimum 4 years in medical device design or manufacturing environment.
• Impeccable integrity and high capacity; strong desire to make work fun
• Strong analytic skills as proven by track record for analyzing and fixing complex problems in products and processes.
• Training or commensurate experience in the science of quality
• Proven ability to lead and motivate across functional boundaries.
• Proven ability to manage through conflicting requirements and make difficult tradeoffs when resources are scarce.
• A passion for doing the vital few efficiently and well.
• Excellent judgment in the presence of competing priorities and incomplete data
• Understands manufacturing metrics.
• Understands basic Excel data analysis operations (e.g. Pareto charts and trend).
• Working Knowledge on Tableau and Snowflake is a plus.
• Able to work in various project teams as the Quality SME.
• Able to communicate work tasks to various project team members.
• Capable of Compiling data in format appropriate for presentation.
• Travel requirement for this position is 10%.

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 COVID19.  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

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 marketcompetitive 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 salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime