Quality Engineer 2 - SinglePort Da Vinci

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 104,000 - 141,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a Quality Engineer II to support product development and operations from concept to commercialization.

You will contribute to design control, risk management, and process validation while aligning with Intuitive's quality processes and regulatory requirements. The role calls for collaboration with cross-functional teams, data-driven problem solving, and ensuring product quality throughout the lifecycle.

Qualifications

• Minimum BS in engineering or STEM required.
• 2+ years in quality engineering or related field in medical devices.
• Experience with design control and risk management from design through commercialization.
• Experience with ISO 13485, ISO 14971 and FDA QSR compliance.
• Ability to navigate quality systems with minimal oversight.
• Strong communication to cross-functional teams.

Responsibilities

• Support manufacturing and cross-functional teams to resolve technical problems.
• Collaborate with product development teams and track progress against schedules.
• Provide GMP/ISO/FDA compliance support and audits.
• Apply PFMEA, RCA, CAPA and process validation techniques.
• Perform data analysis with statistical methods (ANOVA, DOE).
• Support SAP, Trackwise, and Agile-based workflows and documentation.

Skills

Design control

Risk management

pFMEAs

CAPAs

FDA QSR

Electromechanical devices

Quality systems

Root cause analysis

Statistics

Education

Bachelor's in Engineering or STEM

Advanced degree preferred

Tools

SAP

Trackwise

Agile

Tableau

PowerBI

Job description

Quality Engineer 2 - SinglePort 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.

Essential Job Duties

• 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

Qualifications

Required Skills and Experience

• 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

Required Education and Training

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

Preferred Skills and Experience

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

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 Compensation Range Region 1: $104,000 USD - $140,800 USD
Base Compensation Range Region 2: $88,400 USD - $119,700 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.