Technician II - Medtronic (Puerto Rico)
Technician II
Location:
Juncos, Puerto Rico, United States
Requisition #:
17000OUZ
Post Date:
4 hours ago
**Position Description**
Assists with qualification process; troubleshoot any equipment malfunction; set-up and fine-tune equipment.Adjusts equipment setting in order to build samples as per Experiment’s Design, or qualification/validation plans.Conducts any testing and take measurements as required in the plan.Properly documents activities and record test results.Provides direct support to the production line and operators.Monitors process and equipment performance, and takes preventive action.Partners with Engineers, Quality, and Production personnel to quickly contain and prevent any quality related issues.Evaluates potential nonconforming product.Under the guidance of Manufacturing Engineers, participates on equipment Buy-Off activities, performs initial equipment installation and qualification, prepares list of spare parts, and defines PM procedures and frequency.Trains line technicians on equipment functionality, and PM procedures.Physically arranges and moves workstations and equipments as per the latest Layout plan.Assists engineers in implementing ECOs.Prepares technical reports as required.
Position Responsibilities
•Conducts investigation of quality issues and documents as per established policy. Assures product containment within available systems.
•Gathers information for the quality engineers, in order to address product issues
•Performs analysis using lean sigma tools as part of quality issue investigations.
•Assists in the development of training and working standards including, but not limited to, visuals, pictorials, or other mechanisms.
•Assists Quality Engineering in the development / implementation of procedures, work instructions or forms, as required.
•Performs quality audits to the manufacturing line and rearrange schedule based on trending.
•Provides direct support to the production line and operators related to quality issues.
•Provides adequate tools and equipment to ease device inspection.
•Present data or explains situations affecting quality to manufacturing personnel when required.
•Prepares material and data to be presented in quality review meetings.
•Works and implement special projects when required including but not limited to CAPA, Continuous improvement projects, etc.
•Evaluates product/material discrepancies (PRB/MRB), and implement corrective actions on a timely manner
•Performs qualifications / validations for product/processes and equipment, as required.
•Assess adequacy of process inspection points based on process FMEAs.
•Supports product transfers and new implementations.
•Assists in the investigations of quality issues and non-conforming situations as required.
•Prepares and presents trend data pertaining to the calibration area during monthly Quality Review meetings.
•Assists in gathering of information during FDA inspections, Notified Body Audits, Corporate Audits, etc.
•Perform other position duties as assigned.
•Support manufacturing course/certification in the applicable LMS System.
•Support on-the-job training plan to assure personnel compliance.
•Works with document changes in the applicable system (ex. change of manufacturing / quality document changes in Agile)
**Quality Responsibilities**
•Reports any observed or informed process and/or product non-conformities to the Supervisor.
•Finds resolution of Quality Situations at the area of responsibility.
•Reports any complaint regarding a Medtronic product to the Supervisor.
•Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s).
**EHS Responsibilities**
•Acknowledge and maintain commitment with the EHS Policy
•Participate in the development of EHS improvement projects
•Participate actively in the EHS programs to achieve the objectives and targets defined for the area
**Minimum Education**
Associate Degree or 60 undergraduate approved credits as equivalent
**Basic Qualifications**
Background
•Educational: Electronics, Engineering Technology, Industrial Technology or related field
•Experience:
oIntermediate Level:3+ Years with Associates or 0 Years with Bachelors
•Able to read schematics and have an understanding of analog and digital circuits, Operate test equipment and Soldering experience
Skills
•Analytical Thinking
•Problem Solving
•Interpersonal Relations
•Quality and Results Oriented
•Computer Literate
•Basic oral and written communication skills in Spanish and English
**Desired/ Preferred**
**Qualifications**
Background
•Experience in medical device, pharmaceutical, or electronic industry
Education: Associate Degree
Skills
•Teamwork
•Communications
•Continues Improvement
•Project Management
•Good Mechanical Skills, use of small hand tools.
**Working Conditions**
**Mental Components** :
Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document.
**Physical Components** :
Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment.
**Environmental**
Work is performed in building’s interior with normal temperature, good illumination, air condition, clean environment and minimum risk