Gateway Recruiting, INC.
Position
Summary:
The position of SeniorProduct Engineer is responsible for the full life cycle of the metra.
This includes managing performance in the field, supplier and manufacturing related upgrades, and feature enhancements.
As part of a small multi-disciplinary Product Engineering team, the successful candidate will support design activities in the following areas;Lead root cause analyses of field performance issues, manage, and qualify component and supplier migrations, lead design changes to support improved manufacturing yield or system performance, and new features and functionality requested by clinical customers.
This will require close partnership with field-based customer service, operations, and quality teams.
Supporting the creation of assembly instructions and outputs required by the Operations team, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs.
Working closely with the New Product Development and Operations teams throughout development projects with a focus on supporting design reviews and design transfer activitiesInvestigations into the root cause of failures will be conducted in a timely manner, in collaboration with Quality and Product Support (Servicing) departments and reported using the company's investigations processes.
Major
Responsibilities:
Under direction from the SVP of Product Engineering, the Senior Product Engineer will be responsible for:
Investigating device issues, determining, and reporting the root cause (in collaboration with the quality, service, and operations departments), and recommending corrective actions Working on problems for production support, quality improvements, and line extensions.
This includes conducting and supporting problem solving efforts and root cause analysis, CAPA ownership, and identification and evaluation of potential solutions.
Interpreting and understanding the product's intended use, clinical procedures, customer needs and design inputs.
Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record.
Following, learning, and contributing to R&D procedures, such as failure analysis, design controls, and risk management, per the Quality Management System Assisting prototyping efforts and bench testing.
Prepare visualizations and conclusions for presentation to upper management.
Demonstrating ownership and integrity of work, a spirit of volunteerism, a passion for excellence and our products, and a hands-on approach to engineering.
Required
Qualifications:
Bachelor's Degree in Mechanical Engineering or related8 years of work experience Knowledge of mechanical engineering practices and design principles.
Knowledge of design and concept generation, and engineering analysis utilizing CAD and CAE tools.
Knowledge of materials and manufacturing methods.
Preferred
Qualifications:
Medical device industry experience Previous experience in medical devices under ISO 13485 QMSSupplier management Powered by JazzHRAbout the Company:
Gateway Recruiting, INC.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The position of SeniorProduct Engineer is responsible for the full life cycle of the metra.
This includes managing performance in the field, supplier and manufacturing related upgrades, and feature enhancements.
As part of a small multi-disciplinary Product Engineering team, the successful candidate will support design activities in the following areas;Lead root cause analyses of field performance issues, manage, and qualify component and supplier migrations, lead design changes to support improved manufacturing yield or system performance, and new features and functionality requested by clinical customers.
This will require close partnership with field-based customer service, operations, and quality teams.
Supporting the creation of assembly instructions and outputs required by the Operations team, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs.
Working closely with the New Product Development and Operations teams throughout development projects with a focus on supporting design reviews and design transfer activitiesInvestigations into the root cause of failures will be conducted in a timely manner, in collaboration with Quality and Product Support (Servicing) departments and reported using the company's investigations processes.
Major
Responsibilities:
Under direction from the SVP of Product Engineering, the Senior Product Engineer will be responsible for:
Investigating device issues, determining, and reporting the root cause (in collaboration with the quality, service, and operations departments), and recommending corrective actions Working on problems for production support, quality improvements, and line extensions.
This includes conducting and supporting problem solving efforts and root cause analysis, CAPA ownership, and identification and evaluation of potential solutions.
Interpreting and understanding the product's intended use, clinical procedures, customer needs and design inputs.
Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record.
Following, learning, and contributing to R&D procedures, such as failure analysis, design controls, and risk management, per the Quality Management System Assisting prototyping efforts and bench testing.
Prepare visualizations and conclusions for presentation to upper management.
Demonstrating ownership and integrity of work, a spirit of volunteerism, a passion for excellence and our products, and a hands-on approach to engineering.
Required
Qualifications:
Bachelor's Degree in Mechanical Engineering or related8 years of work experience Knowledge of mechanical engineering practices and design principles.
Knowledge of design and concept generation, and engineering analysis utilizing CAD and CAE tools.
Knowledge of materials and manufacturing methods.
Preferred
Qualifications:
Medical device industry experience Previous experience in medical devices under ISO 13485 QMSSupplier management Powered by JazzHRAbout the Company:
Gateway Recruiting, INC.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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