The position of Manufacturing Engineer is within our Cardiometabolic Business Unit located in San Diego, California. This position is responsible for the equipment performance in support of manufacturing goals and company objectives. This position is responsible to troubleshoot and repair complex issues with automated and manual manufacturing equipment, identify inherent equipment issues and create/implement solutions with the use of structured problem solving. This position will work with engineer technicians and vendors to integrate new equipment, and creation and execution of equipment validations FAT, SAT, IQ, OQ and PQ. The Manufacturing engineer will be able to perform preventative, corrective, and breakdown maintenance on all production equipment.
WHAT YOU’LL DO
- Troubleshoot and repair complex issues with automated and manual manufacturing equipment.
- Identify inherent equipment issues and create/implement solutions.
- Responsible for electro mechanical and operational troubleshooting that ensure OEE metrics are maintained month over month.
- Subject matter expert in executing and improving preventative and demand maintenance programs.
- Proactively investigate and determine root cause of the equipment failures.
- Uses computer programs to set-up and troubleshoot equipment issues related to PLC, HMI, Servo drivers and vision systems.
- Leads the implementation of innovate methods for resolving problems and increasing operational efficiency using facts and data.
- Proactively communicates unexpected equipment downtime and delays that will impact production efficiencies.
- Comprehensive understanding and adherence to safety protocols such as but not limited to lock out tag out, use of personal protective equipment and how to work with hazardous materials.
- Maintains procedures and records as per company standards. Generates and updates documentation for manufacturing engineering.
- Provide management with necessary information and reports through the use of excel based data sheets requiring understanding of basic math and graphical functions.
- Train new personal in procedures/policies in regard to equipment maintenance.
- Create and execute equipment validations (FAT, SAT, IQ, OQ, PQ).
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Basic understanding of federal regulations as well as other regulatory and company requirements.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
- Carries out duties in compliance with established business policies.
- Work with equipment owners to provide accurate and timely resolution of issues impacting the manufacturing processes.
- Evaluate, select and order equipment used to support the manufacture of division products.
- Oversee the installation, modification, upgrade and maintenance of manufacturing equipment.
- Implement, document, and maintain controlled, repeatable production processes.
- Create and upgrade equipment operating procedures to be used by manufacturing personnel.
- Identify, investigate and resolve production yield issues or equipment reliability issues.
- Interface with other departments and suppliers to address root cause.
- Responsible for the reliable operation and technical accuracy of manufacturing equipment/systems.
- Accountable for identifying and achieving manufacturing scrap targets, and supporting product cost reduction activities.
- Successful execution of the responsibilities associated with this position results in stable production operations, stable or improving yields and cost metrics, and conformance with site, corporate and regulatory requirements.
EDUCATION AND EXPERIENCE YOU’LL BRING
- BS in Engineering, or equivalent.
- Experience in the design, fabrication, assembly or maintenance of production tools and fixtures.
- 4+ years in technical function supporting automated manufacturing equipment.
- 3+ years in medical device industry.
- Experience with pneumatically operated pick-and-place mechanisms and programming logic for automated manufacturing processes.
- Experience with Allen Bradley PLC codes and Cognex Vision systems is an asset.
- Strong communication skills allowing you to work well with a team.
- Experience with lean/six sigma methodologies is an asset.
- Experience with Solidworks, CAD, Excel, JMP is an asset.
- Experience with design of experiments is an asset.
- Six Sigma Green or Black Belt certification.
- Acts ethically and takes accountability for achieving outcomes.
- Avoids getting stuck in a “one right way” approach – remains open minded to new ideas.
- Proactively listens to internal/external customers and clarifies expectations.
- Promptly and effectively handles issues and problems.