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Sr Manufacturing Engineer
hace 1 mes
**About the position**:
**Responsabilities**
- Daily support to the manufacturing activities in order to meet established goals for safety, quality, cost and production.
- Based on key performance indicators data such as yield, nonconforming material or Leadtime, takes action to maintain indicators under control.
- Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
- Understands product cost components and its interactions, (direct & indirect material costs, labor, overhead).
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- 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.
Identifies and mitigates risks associated to equipment technical knowledge, spares availability and external technical service
- Evaluates the financial, process or quality impact, derived from product & process changes.
- 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 excecated activities on manufacturing systems for example, update routers, BOM's or to generate new part numbers.
- Coordinates the activities related to new part numbers 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 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 CAPA investigation processes, or exception documents such as complaints investigations.
**Qualifications**
- Bachelor's Degree.
STEM careers.
- 6+ years of manufacturing/process development experience
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Willing to travel.
- Experience with continuous improvement methodologies.
Such as lean manufacturing techniques, value stream mapping, or similar.
- Knowledge of FDA, GMP, and ISO guidelines is required.
- Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.
- Experience in project management.
- Advance command of English (written and speaking).
Required
- (3-5) + years prior experience in medical devices manufacturing.
- Performance management
- Shift B
**Competencies**:
- Values: Integrity, Accountability, Teamwork, Innovation
