Manufacturing Process Development Expert

hace 5 días


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

**About Our Company**

We are a leading global technology company, dedicated to connecting and ensuring the integrity of products that create a safer, more productive world.

**Job Summary**

We seek an experienced Manufacturing Process Development Engineer to join our team in driving process improvements and optimizing production efficiency.

**Responsibilities**

- Utilize statistical techniques to inform decision-making and draw conclusions from data analysis.
- Develop a deep understanding of product cost components and their interactions to optimize production processes.
- Prepare comprehensive reports by collecting, analyzing, and summarizing information and trends, ensuring accurate lifecycle management.
- Lead installation/validation activities for new or existing production lines, ensuring regulatory compliance and meeting customer requirements.
- Estimate validation costs and ensure timely budget allocation within the financial cycle.
- Source equipment/fixtures according to production needs, considering factors like obsolescence, redundancy, and capacity expansion.
- Maintain equipment operational efficiency by coordinating calibration, maintenance, and repair services, adhering to manufacturer guidelines and established procedures.
- Analyze equipment performance data, trends, and metrics to ensure optimal lifecycle management.
- Identify and mitigate risks associated with equipment technical knowledge, spares availability, and external technical service.
- Evaluate the financial, process, or quality impact derived from product and process changes, providing informed recommendations for improvement.
- Ensure production line output meets product specifications, maintaining high-quality standards.
- Establish clear criteria for conforming/non-conforming products and test methods used for verification.
- Navigate and execute activities on manufacturing systems, such as updating routers, BOMs, or generating new part numbers.
- Coordinate new part number implementation activities, ensuring seamless integration into existing processes.
- Maintain master plans (MPs) current and compliant with regulations, ensuring adherence to best practices at the manufacturing floor level.
- Support direct labor's and indirect labor's training process, promoting skill development and knowledge sharing.
- Participate in the identification and investigation of non-conforming products, applying root cause problem-solving techniques to eliminate causes and implement controls.
- Lead or support CAPA investigation processes or exception documents, such as complaint investigations, ensuring thorough analysis and corrective actions.
- Identify and implement continuous improvement projects focusing on key areas like safety, quality, production, and cost, utilizing project management tools effectively.
- Provide technical guidance and supervise exempt and non-exempt personnel, ensuring correct training and performance management.
- Contribute to departmental budget preparation, aligning resource allocation with strategic objectives.

**Qualifications**

- Bachelor's degree in Mechanical/Material Science or equivalent discipline.
- Minimum 3-5 years prior experience in medical devices manufacturing or related field.
- 6+ years of manufacturing/process development experience.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
- Familiarity with Grinding process, Overmoulding, and extrusion is an asset.
- 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 applying root cause problem-solving methodologies.
- Project management experience is beneficial.
- Advanced command of English language (written and speaking).



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