Quality Engineer 3 (Finance)
Company Description
At 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.
Job Description
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.
Intuitive seeks a strong technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems.
The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization. You will not abide "process red tape", instead passionately seek the most efficient way to build in product quality. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.
Roles & Responsibilities:
In general, Quality Engineering is a stakeholder and shares responsibility for:
- Setting data-driven priorities for continuous improvement and ensuring quality/reliability/safety is built into Intuitive's product design & manufacturing by partnering with Design Engineering, Manufacturing Engineering, and Supplier Quality.
- Ensuring data quality, process quality for anything that affects Intuitive's product or patient outcome, including the improvement of SOPs, DOPs, etc.
- Supporting deep technical failure analysis, root cause analysis, resolution, correction and prevention for challenging quality issues.
- Generating risk assessments for product in the field, including recall assessment by collaborating with compliance teams.
The main responsibilities for the individual sought by SP Product Quality are as follows. These responsibilities are aimed at ensuring effective product introduction and production support, maintaining high quality standards, and fostering continuous improvement within the organization.
New Product Introduction and Production Support:
- Partner with manufacturing and supplier teams to effectively transfer products and processes into the production environment and provide ongoing support for these products.
- Conduct production facility validation planning, execution, and documentation, including Minimum Viable Product/Release (MVP/MVR) in Sunnyvale, CA, and assist in production transfer activities to other sites as needed.
- Provide support for product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment.
- Offer quality engineering support for product-related issues arising from manufacturing and suppliers, manage containment, assess risks and product impacts, determine dispositions, and make escalation decisions when necessary.
- Analyze product failures and non-conformances, drive product and process improvement opportunities, conduct failure investigations, review engineering assessments, and support projects addressing these failures.
- Plan and direct the creation of quality standards, control and assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices, utilizing clinical and engineering knowledge.
- Provide expertise in change assessments (product and process) and guide other quality engineers on process validations, statistics, risk-based sampling, and measurement system analysis.
Leadership & Continuous Improvement:
- Lead and represent Product Quality at monthly and quarterly review meetings, focusing on Quality Data and Operations Review.
- Identify, present, propose, and drive continuous improvement initiatives by conducting trend analysis on reported manufacturing quality notifications and post-market complaints, and collaborate with engineering partners.
- Assist in performing escalation assessments and driving necessary corrective and preventive actions (PIRs, CAPAs, etc.).
- Support internal and external audits, including preparation and direct interaction with auditors.
- Plan and direct the creation of quality standards, quality control and assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices, utilizing clinical and engineering knowledge.
Skills, Experience, Education, & Training:
- Good understanding of medical device company manufacturing operations and risk-based approaches to quality
- Minimum Education: Bachelor's degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
- Minimum 5+ years of working experience in Quality Engineering, or in manufacturing environment; minimum 4 years in medical device design or manufacturing environment.
- Impeccable integrity and high capacity; strong desire to make work fun
- Strong analytic skills as proven by track record for analyzing and fixing complex problems in products and processes.
- Training or commensurate experience in the science of quality
- Proven ability to lead and motivate across functional boundaries.
- Proven ability to manage through conflicting requirements and make difficult trade-offs when resources are scarce.
- A passion for doing the vital few, efficiently and well.
- Excellent judgment in the presence of competing priorities and incomplete data
- Understands manufacturing metrics.
- Understands basic Excel data analysis operations (e.g., Pareto, charts, and trend).
- Working Knowledge on Tableau and Snowflake is a plus.
- Able to work in various project teams as the Quality SME.
- Able to communicate work tasks to various project team members.
- Capable of Compiling data in format appropriate for presentation.
- Travel requirement for this position is 10%.
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.
Base Salary Range Region 1: $125,900 USD - $181,100 USD
Base Salary Range Region 2: $107,000 USD - $154,000 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
