Quality Engineer 2 Multiport Da Vinci (Sustaining)

Primary Function of Position

As Intuitive s 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 ever-better 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 hands-on experience in solving tough engineering problems your fascination with complex electro-mechanical devices and your passion for the best practices to design monitor and improve product and process.

The position is a quality engineer-2 based out of Peachtree corners GA and will support manufacturing and remanufacturing of systems for the Davinci Multiport business unit.

Essential Job Duties

• Initial roles and responsibilities for this position will include the following:
• 70% involvement in supporting sustaining manufacturing operations 15% design controls and 15% quality advocacy (assistance in quality improvements).
• Manufacturing support:
  • Support manufacturing processes including failure analysis documentation review and approval tooling qualification and defect containments.
  • Support development and execution of process validation and verification test plans protocols and reports.
  • Support production ramp and work cross functionally on issue and support continuous improvement projects.
  • Support investigation and disposition of non-conformances both internal and supplier related.
• Product development:
  • Assist in executing design verification & validation efforts by working with cross functional teams.
  • Contribute in risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans.
  • Ensure design changes are established and implemented according to ISI standards and applicable regulations.
  • Recommend design processes and methods to meet quality goals (DFX etc.).
• Quality Advocacy:
  • Develop and apply corporate-level quality metrics.
  • Ensure the quality system requirements are effectively established and maintained.
  • Lead and manage quality initiatives in one or more areas of product and processes quality.
  • Evaluates deviations and non-conformances and supports resolution of quality issues
  • Supports process validation and verification.
• Perform risk analysis and determines quality disposition for variance requests and non-conformances
• Releases process and document changes through engineering change orders and deviations using ISI change control process
• Ensures successful on-time completion of department projects communicates constraints to direct management when successful project completion is at risk
• Performs other duties as assigned by the management.

Qualifications :

Required Skills and Experience

Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:

• 2 years of relevant experience in medical device or manufacturing environment.
• Understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
• Understands product risk management experience in generate FMEA and process FMEA.
• Understands Design Controls Change Controls Product and Engineering Processes.
• Experienced in leading product containment and rework activities.
• Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Whys control charts fishbone diagram).
• Understands typical Excel data analysis operations (e.g. Vlookup Pivot table and pivot chart functions) Able to create Multi-source report trends and interprets data with minimal oversight.

• Ability to communicate effectively both verbally and in writing Integrity: Accepting and adhering to high ethical moral and personal dealing with others values in decisions communications actions and when Dealing with others
• Ability to work independently and handle tasks with competing priorities effectively.

Required Education and Training

•  Education: Bachelors degree in electrical mechanical or system engineering math or physics. Advanced degree preferred.

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 employeeswho 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 governments 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 employeesstart 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.

Remote Work :

No

Employment Type :

Full-time