Intuitive's da Vinci® Surgical System adoption requires a focused team to drive reliability, quality, and safety to ever-better levels across product in use, product in manufacturing, and product in design.
Requirements
- 5+ years of working experience in Quality Engineering, minimum 3 years in medical device design or manufacturing environment.
- Demonstrated 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 Controlled Environment Room controls including periodic Bioburden and Endotoxin testing.
- Demonstrated understanding of single use disposable requirements (ex – sterilization requirements).
- Understands Design Controls, Change Controls, Product, and Engineering Processes.
- Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
Responsibilities
- Includes Design Control projects, production line support and failure investigation and providing guidance on Quality tools and project management.
- Develop and apply corporate level quality metrics.
- Lead and project manage quality initiatives in one or more of these focus areas: Product Quality Data Quality Process Quality
- Handle projects of various product and subsystem types (electromechanical, Mechanical Hardware, instruments, Disposable accessories like seals, drapes etc).
- Ensure that the essential performance aspects are inspected for as part of repair test process.
- Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
- Support analysis and disposition of discrepant material.
Other
- Able to navigate quality and compliance system with minimal oversight on individual projects.
- 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.
- Can present information in various forms and forums, collaborates with peers across functions. Experience in presenting to cross functional mgmt. communications. (e.g. report writing, presentations, QRB presenter).
