Sr Quality Engineer

Primary Function of Position

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 ever-better levels. This focus applies to product in use product in manufacturing and product in design. Help us powerfully drive our quality mission 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 for a Senior Quality Engineer located in Peachtree Corners GA. The role involves supporting the System Service business unit for the Davinci Multiport (MP) business unit.

Essential Job Duties

• The initial roles and responsibilities for this position are as follows:
  - 60%: Support sustaining manufacturing operations including failure analysis.
  - 25%: Engage in design controls.
  - 15%: Advocate for quality and drive continuous improvements.
• Manufacturing support:
  • Support manufacturing processes by reviewing and approving quality documentation qualifying equipment and managing defect containment.
  • Ensure all manufacturing activities comply with ISI procedures and regulatory requirements.
  • Assist in the development and execution of process validation and verification test plans protocols and reports.
  • Maintain and update site-level process FMEA and risk management files as needed.
  • Aid in production ramp-up and collaborate cross-functionally to address issues and drive continuous improvement projects.
  • Investigate and resolve non-conformances including those related to internal processes and suppliers.
• Failure Analysis:
  • Provide quality expertise to the failure analysis team to analyze the returned product (RMA).
  • Conduct in-depth technical analysis grounded with the physics of failure.
  • Review and interpret complex data analyses leveraging a deep understanding of our products hardware and software the physics of failure and the conditions of use in clinical and operating room environments.
• Product development:
  • Represent service Quality in the design control process including planning and execution of design verification and validation and risk management.
  • Participate in risk management process ensuring that all service risks were properly identified/assessed and update risk management files accordingly.
  • Collaborate with design/sustaining cross functional teams and understand the impact of the change to service organization and ensure service deliverables were identified and implemented.
  • 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.
  • Create process and review various types of Quality Notifications and Change Orders.
  • Apply corporate level quality metrics. Lead quality meetings e.g. QDR (Quality Data Review).
  • Lead and project manage quality initiatives in one or more of these focus areas: Product Quality Data Quality and Process Quality.
  • Perform mock audits and Gemba walks to ensure compliance with ISI QMS.
• Continuous Improvement:
  • Review line non-conformance data and identify the trends and drive the continuous improvement projects including identifying the root cause implementation and closure.
  • Review data proactively and take actions to mitigate the issue from occurring.
• Support internal and external audits including audit preparation reviewing the front room documents and interacting with the auditors.
• Escalates issues/potential issues to direct management that could impact compliance patient safety or surgical efficacy.
• 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

• Education: Bachelors degree in electrical mechanical or system engineering math or physics. Advanced degree preferred.
• Minimum of 7 years of working experience in Quality Engineering or in manufacturing environment minimum 5 years in medical devices or manufacturing environment.
• Demonstrated proficiencies of 21 CFR 820 ISO 13485 and ISO 14971 requirements for making process or design changes.
• Understands product risk management experience in generating/updating FMEAs (dFMEA pFMEA and uFMEA).
• Understands Design Controls Change Controls Product and Engineering Processes.
• Proficient with generation and execution of Qualifications Validation protocols and Quality Assurance Procedures.
• 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.
• Capable of thinking independently and make decision based on limited information.

• 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.

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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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 salary ranges are listed.

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

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 salary ranges are listed.

Remote Work :

No

Employment Type :

Full-time