Description
Job Summary:
Performs intermediate-complexity technical activities in prototyping and testing of medical products, with a focus on process optimization and quality assurance.
Key Highlights:
1. Process optimization and quality assurance for medical products
2. Leadership in assembling complex prototypes and data analysis
3. Technical support and coordination with suppliers
**Description and Responsibilities:**
**Schedule:** Monday to Friday, from 8:00 AM to 5:48 PM, with a 1-hour lunch break.
**Level:** Operational
**Employment Type:** Permanent – CLT
Carrying out technical activities of intermediate complexity in the prototyping and testing of medical products, with a focus on process optimization and quality assurance.
* Making and monitoring impressions of components and resins for the creation of complex anatomical models.
* Coordinating the assembly of products for simulated use and optimizing assembly processes.
* Managing stock control of materials and supplies, ensuring availability and quality.
* Carrying out bench, traction and simulated use tests autonomously, interpreting the results for improvement.
* Contributing to the drafting of test protocols, creating detailed procedures.
* Supervising and conducting performance, mechanical and functional tests on prototypes, ensuring that regulatory and internal procedures are followed.
* Lead the assembly of complex prototypes, identifying assembly improvements and adjusting the process to maximize efficiency and quality.
* Collect, interpret and analyze test data, preparing detailed reports that document performance and identify potential failures, proposing technical improvements.
* Monitor processes to ensure that tests and prototypes comply with applicable regulations (ISO, FDA), proposing adjustments where necessary.
* Provide guidance and technical support to junior staff, ensuring that they understand and follow established processes.
* Coordinate with external suppliers and internal teams for the selection and procurement of materials, overseeing the process to ensure that specifications are met.
* Prepare and review technical documentation for testing processes and procedures, including operating manuals, test records, and compliance documents.
Execution of intermediate-complexity technical activities in prototyping and testing of medical products, with a focus on process optimization and quality assurance.
* Execute and monitor impressions of components and resins for the creation of complex anatomical models.
* Coordinate the assembly of products for simulated use and optimize assembly processes.
* Manage inventory control of materials and supplies, ensuring availability and quality.
* Conduct bench, tensile, and simulated-use tests autonomously, interpreting results for improvement.
* Contribute to the development of test protocols, creating detailed procedures.
* Supervise and perform performance, mechanical, and functional tests on prototypes, ensuring compliance with regulatory and internal procedures.
* Lead the assembly of complex prototypes, identifying assembly improvements and adjusting the process to maximize efficiency and quality.
* Collect, interpret, and analyze test data, preparing detailed reports documenting performance and identifying potential failures, proposing technical improvements.
* Monitor processes to ensure tests and prototypes comply with applicable regulations (ISO, FDA), proposing adjustments as necessary.
* Provide guidance and technical support to junior staff, ensuring understanding and adherence to established processes.
* Coordinate with external suppliers and internal teams for material selection and procurement, overseeing the process to ensure specification compliance.
* Develop and review technical documentation for testing processes and procedures, including operation manuals, test records, and compliance documents.
**Requirements:*** Advanced technical training or ongoing degree in related fields (Mechanical Engineering, Production Engineering).
* At least 3 years' experience in prototyping and testing.
* Intermediate knowledge of 3D printing processes and inventory management.
* Knowledge of Biomedical Materials: Applies knowledge about biomedical materials used in medical devices, considering properties, applications, and limitations during prototyping and testing.
* Proficiency in Design Software: Uses design/CAD software for reading, simple adjustments, and support in prototype preparation, ensuring alignment with technical specifications.
* Basic English: Uses English at a basic level to understand technical terms, software commands, and simple instructions found in documents and drawings.
* Prototype Preparation: Executes prototype preparation with greater autonomy, following technical procedures, ensuring quality, traceability, and project compliance.
* Rapid Prototyping: Applies rapid prototyping techniques for prototype construction and adjustment, contributing to agile development and validation cycles.
* Advanced technical education or ongoing undergraduate degree in related fields (Mechanical Engineering, Production Engineering).
* Minimum 3 years of experience in prototyping and testing.
* Intermediate knowledge of 3D printing processes and inventory management.
* Knowledge of Biomedical Materials: Applies knowledge about biomedical materials used in medical devices, considering properties, applications, and limitations during prototyping and testing.
* Proficiency in Design Software: Uses design/CAD software for reading, simple adjustments, and support in prototype preparation, ensuring alignment with technical specifications.
* Basic English: Uses English at a basic level to understand technical terms, software commands, and simple instructions found in documents and drawings.
* Prototype Preparation: Executes prototype preparation with greater autonomy, following technical procedures, ensuring quality, traceability, and project compliance.
* Rapid Prototyping: Applies rapid prototyping techniques for prototype construction and adjustment, contributing to agile development and validation cycles.
**Benefits:**
Internal benefits, Health Insurance, Dental Insurance, Life Insurance, Meal Voucher, Food Voucher, Transportation Voucher