Quality Engineer - SinglePort Da Vinci

Quality Engineer 2 - Single Port Da Vinci (Finance) Company Description / Job Description

Primary Function of Position The Quality Engineer II supports product development and
operations from concept through commercialization and will serve as the core team
member with the cross-functional product development and operations teams. The
Quality engineer will provide support for design control and risk management, Design
for Reliability and Manufacturing, product Development Life Cycle, and Process
Validation. In addition, this position will play an active role to ensure that the developed
products meet quality standards consistent with Intuitive' s quality processes, while
meeting design control and regulatory requirements.

• Support manufacturing and work cross-functionally to resolve technical problems
• Work closely with product development teams.
• Monitor priorities and tracks progress against schedules; and communicates
  status to management.
• Provide support in the implementation and policing of GMP, ISO and FDA
  requirements.
• Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non
  - Conformance, and Process Validation
• Experience with product investigation, Identifying root cause and implementing
  appropriate solutions
• Familiarity with data analysis tools and statistical methods (i.e., ANOVA, DOE,
  etc.)
• Provide statistical support and analytical problem solving for manufacturing,
  technical services, and product development to identify root cause of problems
• Experience with computerized systems, such as SAP, Trackwise, Agile, etc.
• Experience in product design changes, manufacturing changes, supplier
  changes and the associated requirements to execute such changes.
• Support internal and external audits, including preparation and direct interaction
  with auditors.
• Support, designs and implements methods and/or procedures for inspecting,
  testing, and evaluating the precision and accuracy of products, components, sub
  - assemblies and/or production equipment.
• Author technical documents with sufficient clarity, detail and correctness
• Familiarity with FDA guidance documents and ISO and ASTM standards related
  to quality and medical device industry is an asset.
• Other duties as assigned

• Minimum Education:
  
  Bachelor's in engineering or STEM
• Advanced degree preferred with 2+ years of working experience in Quality
  Engineering or related field, minimum 2 years in medical device environment.
• Experience and familiarity with respect to design control and risk management
  from early design and development through commercialization.
• Demonstrated experience with electromechanical devices.
• Experience with medical standards: ISO 13485, ISO 14971 and FDA Quality
  System Regulations with a focus on design controls and design optimization.
• Able to navigate quality system with minimal oversight on individual projects.
• Balanced risk decision making to drive product quality, gain consensus, and work
  through technical challenges.
• Able to articulate complex information to teams, including management

• Minimum BS in Engineering or STEM discipline is required.
• Minimum 3 years of experience in a regulated industry with 1 years in Medical Device

• Experience with data analysis tool. i.e., Tableau, PowerBI, etc.

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.

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In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical…