MAIN PURPOSE OF 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 installation and validation of production lines as well as the lifecycle management of equipment
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 appropriate 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 equipment's, process, product and test method validations.
Estimates validation activities cost and assures it is budgeted within 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.
Able to navigate and execute activities on manufacturing systems for example, update routers, BOM's or to generate new part numbers and ZFINs.
Coordinates the activities related to new ZFIN's implementation.
Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.
Supports DL's & IDL's training process.
Participates with external cross functional teams(ie, RA, R&D, QA) representing the ME function.
Leads or supports local cross functional team activities.
Participates in the identification and investigation of Non-conforming products. Uses Root cause problem solving.
Leads or supports CAPA investigation processes, or exception documents such as complaints investigations.
Leads or supports continuous improvement projects for any of the main key areas : safety, quality and production.
May supervise and provide technical assistance to non-exempt personnel, being accountable for their correct training and performance management
Bachelor’s Degree in Engineering.
3-6 years of working experience on similar roles.
Statistical techniques knowledge (DOE, SPC).
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). Language Proficiency
Intermediate Commands of English / Required
1-3 years of experience on medical device industry desired.