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.
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. PLEASE NOTE THAT THIS POSITION IS A FIXED-TERM POSITION FOR 18 MONTHS TO COVER A MATERNITY LEAVE.
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 optics, and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization. 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.
New Product Development and Sustaining/Manufacturing Support
Handle projects of various product and subsystem/component types (electrical, mechanical, optical, etc).
Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments.
Support development and execution of process validation and verification test plans, protocols, and reports.
Support development and execution of manufacturing line qualification plans, protocols, and reports. Support and drive SMVP/R projects.
Provide quality expertise to the quality engineering support team to analyze the product 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.
Quality Advocacy and Project Management
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.
~ Any other Quality Engineering related function/responsibility as directed by the manager.
Bachelor degree in electrical, mechanical or system engineering, math, or physics. Experience: 5+ years of working experience in Quality Engineering, minimum 3 years in medical device design or manufacturing environment.
Language: Fluent in both English and local language.
Capable to navigate quality and compliance system with minimal oversight on individual projects.
Demonstrated understanding of CFR 21 820 / ISO 13485 requirements for making process or design changes as well as MDSAP and MDR requirements for supporting internal and external audits.
Knowledge in Design Controls, Change Controls, Product, and Engineering Processes.
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).
Knowledge in typical Excel data analysis operations (e.g. Capable to create Multi-source report, trends, and interprets data with minimal oversight.
Can present information in various forms and forums, collaborates with peers across functions.