Costa Rica-Coyol
Hybrid Roles:
About the role:
Evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Improve existing manufacturing processes and act as liaison between production and engineering group in resolving problems encountered on the production floor. Assist with the introduction of new products into the Operations production area.
Your Responsibilities include:
- Collaborates cross functionally to understand design inputs and outputs on acquired entity’s design control structure.
- Performs documentation remediation including process risk management, validation plans, validation executions, test method validation executions, manufacturing instructions, training plans, and new process development to ensure requirements of the BSC quality system are achieved.
- Define business requirements and the Standard Operating Procedures related to manufacturing processes driven by the Boston Scientific Quality System to support production and business goals.
- Participates in project teams typically including one of the following: identifying and implementing process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance; designing, performing, and documenting engineering test experiments to evaluate product/product performance; participating in Quality improvement activities; designing, developing, testing, and validating equipment, tools and fixtures; analyzing and interpreting process models and recommending process improvements; evaluates external process technologies; and other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific narrow area of assignments.
- Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
- Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
- Has working knowledge of Risk Management & Failure mode and effect analysis (FMEA) requirements.
- Interfaces with assemblers, production supervisors, and engineers in troubleshooting problems on the production floor.
- Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans.
- Acts independently to implement and follow through.
- Perform root cause analysis of failed product.
- Participates in project planning and scheduling.
- Optimize processes for yield improvements, cycle time improvements, and scrap reduction.
- Attends and contributes to product core team meetings.
- Performs responsibilities required by the Quality System and other duties as assigned or requested.
What we're looking for:
- Bachelor or Licenciature degree in Mechanical, Electromechanical, Electronic, Biomedical, Chemistry, Industrial'Electrical Industrial Maintenance. or Equivalent experience.
- Experience in Manufacturing Transfer Activities
- Experience as Manufacturing Engineer in Medical devices industry.
- English Level desired: 80-85%.
- Experience: At least 3 years
- Able to coordinate tasks with different functions to ensure execution of assigned deliverables.
- Please Submit resume in English
- Desired knowledge: Process Manufacturing Certification, Problem Solving, Regulatory industry management, Networking, Process Validations, Statistical and Experimental Analysis, DOE, Tools (Statistics, Technical Manuals, Kaizen, Six Sigma)
- Please Submit Resume in English