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 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.
- Maintains systems that support the monitoring of 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 basic statistic tools.
- Performs installation/validation activities for new or existent production lines, meeting regulatory requirements.
That includes equipments, process, product and test method validations.
- 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.
- Has knowledge and expertise on product requirements and specifications.
- Understands potential risks related to product malfunctions.
- 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.
- Maintains manufacturing systems such as SAP routers and BOM's current.
- Maintains MP's current and compliant to regulations.
Ensures practices at the manufacturing floor adhere to them.
- Supports DL's & IDL's training process.
- Supports local cross functional team activities.
- Participates in the identification and investigation of Non-conforming products.
Uses Root cause problem solving techniques to identify and eliminate causes, implements controls and define preventive activities.
- Leads or supports continuous improvement projects for any of the main key areas: safety, quality and production.
- Provide technical assistance to non-exempt personnel, being accountable for their correct training.
QUALIFICATIONS
- Bachelor's Degree.
STEM careers.
- 0 to 2+ years of working experience on similar roles.
- Statistical techniques knowledge (DOE, SPC) is required.
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Willing to travel
- Intermediate Commands of English to Advance Commands of English / Required
Preferred Qualifications & Education
- Desired experience in validation plans for medical industry products and
processes and root cause problem solving methodologies
- Knowledge of FDA, GMP and ISO guidelines.