JOB DESCRIPTION: MAIN ROLE The manufacturing engineer position develops and implements optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; is also responsible for the activities related to instalation and validation of production lines as well as the lifecycle managment of equipments.
MAIN RESPONSIBILITIES
- Daily support to the manufacturing activities in order to to meet established goals for safety, quality, cost and production.
- Monitors and analyzes data related to key performance indicators such as yield, nonconforming material or leadtime. If indicators show an adverse trend, works with the functional team to plan and implement appropiate changes.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
- Performs installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipments, process, product and test method validations. Estimates validation activities cost and assures it is budgeted withing financial cycle.
- Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion.
- Has direct relation with vendors to define equipment suitability.
- Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.
- Analyzes equipment data, trends, and performance to assure correct lifecycle management.
- Analyzes equipment data, trends, and performance to assure correct lifecycle management.
- Knowledge and expertise on product requirements and specifications. Understands potential risks related to product malfunctions.
- Supports product changes activities such as new materials evaluation, vendor changes, specification change request analysis
- Assures that production lines output meet the specifications of the product. Has clear criteria of conforming/ non conforming product and the test methods used for verifying conformance.
Qualifications:
- Bachelor’s Degree in Engineering careers such as Mechanical, Electromechanical or related field.
- 3-7 years of working experience on similar roles. Relevant experience in equipment validations.
- Statistical techniques knowledge (DOE, SPC).
- Willing to travel.
- Familiar with Lean manufacturing concepts and continuous improvement methodologies.
- Knowledge of FDA, GMP and ISO guidelines.
- Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Intermediate command of English (written and speaking). Required
JOB FAMILY:
Manufacturing
DIVISION:
CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:
Costa Rica Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2
ADDITIONAL LOCATIONS:
WORK SHIFT:
Crcww2Nt (Costa Rica)
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Work in a clean room environment
