Primary Function of Position:
Under general supervision, follows oral and/or written instructions in performance of a wide variety of inspections and testing of complex medical instrumentation and documents findings in Quality Management System. Responsible for timely processing and dispositioning of returned instruments and accessories.
Roles & Responsibilities & competencies
- Perform failure analysis of defective instruments and accessories by evaluating the mechanical, electrical, and physical characteristics of returned items
- Documenting failure analysis findings in clear and concise way in QMS system
- Regular communication with failure analysis engineering group and post market surveillance
- Regular use of diagnostic software for localizing equipment and system problems, specialized testing equipment, analyzers, digital oscilloscopes, digital multimeters, clocks, timers, calipers, voltmeters, power supplies, rulers, and other test equipment as required
- Manage Discrepant returns and escalate to appropriate teams
- Assist Advance FA team on regulatory requirements in resolving “Reportable I/A” events and “Recalled” instruments
- Understand wiring diagrams, schematics, assembly drawings, fab drawings, mechanical component drawings.
- Ability to verify assembly documentation accuracy, read engineering drawings etc. Sets up and operates machines/equipment /fixtures needed to perform inspection and testing processes.
- Properly completes required documentation in QMS
- Dispose bio-hazardous material as required
- Maintains knowledge of DOP’s, SOP’s and MPI’s pertaining to I/A RMA operations
- Reports quality issues and provides details necessary to create quality notification (VR, PL) records transactions in SAP as needed to preserve traceability.
- Able to work and clearly communicate with other personnel and across departments
- Follows all corporate, safety, SOP, DOP procedures and regulations
- Maintains a clean and orderly workstation
- Communicates process flow recommendations to Leads/Supervisor/Manager or designee
- Maintains an excellent attendance record
- Able to successfully prioritize and manage multiple projects
- Acute attention to detail; excellent organizational skills.
- Able to logically address, analyze and resolve problems.
- Able to maintain a professional demeanor and diplomacy when dealing with others.
- Exercises sound judgment while working to resolve critical issues.
- High level of professional integrity and ethics.
- Clearly understands problems, areas of risk, and areas for improvement within work unit, including the processes and procedures.
Skills, Experience, Education, & Training:
- Education and/or Experience: Minimum High school diploma and AA or equivalent Minimum of AA or college degree preferred; three to five years related experience or training; or equivalent combination of education and experience
- Language Skills: Ability to read, write and understand English. Ability to read and comprehend complex instructions, correspondence, and memos. Ability to write in a clean and concise manner. Ability to effectively present information in one-on-one and small group situations to other employees, supervisors, or engineers
- Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute averages, ratios, and percentages and to draw and interpret bar graphs and line graphs. Ability to determine the minimum, maximum and nominal value when provided with a specification and a tolerance
- Reasoning Ability: Ability to apply logical, sensible understanding to carry out instructions. Ability to deal with situations including up to several variables. Ability to report actual or potential quality issues. Ability to suggest and implement process improvements.
- Computer skills: Proficient in use of personal computers as part of daily work, including knowledge of the Microsoft Office suite. Knowledge of SAP ERP System, ACCS (Agile) system (our quality system) desired
- Ability to work varying shifts.
- Ability to work in a team environment
- Ability to lift 50lbs.
- Able to use office and test equipment in a typical office/light manufacturing environment.
- Repetitive motion. Substantial continual motion.
- Excellent hand-eye coordination.
- Vision abilities required include close, distance, color, depth and ability to adjust focus.
- Production & repairs environment, including handling devices with potential biohazards
- Some work in controlled environment with handling of unsterilized medical instrumentation
- General knowledge of clean and organized work areas and practices.
- General knowledge of PPE usage
- High urgency and stress associated with customer deadlines.
- Some risk of exposure to electrical shock and commonly used chemical compounds such as epoxy, denatured alcohol and acetone.
- Willing and able to work extended hours when necessary.
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.
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.
Intuitive, headquartered in Sunnyvale, Calif., is the pioneer and a global leader in robotic-assisted, minimally invasive surgery. Intuitive... Read more