Senior Process Development Engineer

hace 2 semanas

San Francisco, Heredia, Costa Rica Te Connectivity A tiempo completo

**What your background should look like**:
**Main Responsabilities**
- Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
- Understands product cost components and its interactions.
- 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.
- 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.
- 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.
- Identify and implement continuous improvement projects for any of the main key areas: safety, quality, production and cost, using the appropriate project management tools.
- May supervise and provide technical assistance to exempt and non-exempt personnel, being accountable for their correct training and performance management.
- Provides inputs for the departmental budget preparation.
**Qualifications**
- Bachelor's Degree in Mechanical/ Material or equivalent discipline.
Plus 3-5 years prior experience in medical devices manufacturing.
- 6+ years of manufacturing/process development experience
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Experience or knowledge in Grinding process, Overmoulding and extrusion is a plus.
- Experience with continuous improvement methodologies.
Such as lean manufacturing techniques, value stream mapping, or similar.
- Knowledge of ISO 13485 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

**Competencies**:

- Values: Integrity, Accountability, Teamwork, Innovation

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