Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
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 Sr.Quality engineer based out of Peachtree corners, GA and will support manufacturing and remanufacturing of systems for the Davinci Multiport (MP) business unit.
Essential Job Duties
- Initial roles and responsibilities for this position will include the following:
60% involvement in supporting design and sustaining manufacturing operations, 25% design controls and 15% quality advocacy and driving continuous improvements.
- Manufacturing support:
- Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
- Ensure manufacturing activities follow ISI procedures and regulations.
- Support development and execution of process validation and verification test plans, protocols, and reports.
- Maintain site level process FMEA and risk management files and update as required.
- Support production ramp and work cross functionally on issue and drive continuous improvement projects.
- Support investigation and disposition of non-conformances, both internal and supplier related.
- Product development:
- Strong contributor to the planning and execution of design controls, risk management, and design verification/validation for design changes for system and subsystems.
- Participate in risk management process ensuring that all the risks were properly identified/assessed and update risk management files accordingly.
- 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.
- 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.
- Supporting establishment of new PTC site including drafting and execution of Master validation plans, line transfers, equipment moves.
- Perform risk analysis and determine quality disposition for variance requests and non-conformances.
- Releases process and document changes through engineering change orders and deviations using ISI change control process.
- 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.
- Perform deep technical failure analysis based on the physics of failure.
- Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
- Performs other duties as assigned by the management.
Required Skills and Experience
- Minimum Education: Bachelor’s 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 Why's, 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.
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 Employment 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.
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.
Base Salary Range Region 1: $139,400 USD - $200,600 USD
Base Salary Range Region 2: $118,500 USD - $170,500 USD
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.