- Responsible to provide support to multiple projects concurrently, consisting of new product development from concept through production, applying, revising and maintaining quality standards with an emphasis on process development and design for manufacturing.
- Will aid in the new product development process, from concept to launch, by identifying effective and efficient assembly techniques and manufacturing processes to be used.
- Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.
- Analyzes reports and/or returned products and recommends corrective action.
- Develop and execute process and product protocol.
- Knowledge of applicable domestic and international regulations and standards (QSR,MDD,13485 and CMDCAS).
- Develop statistical process controls and analyze data.
- Optimize operating parameters. Lead, monitor and control progress of projects to ensure sound application of engineering principles used, and design intent is being achieved.
- Select, analyze, design and improve mechanical and electrical manufacturing procedures and engineering systems for medical devices.
- Demonstrate a primary commitment to patient safety, product quality and compliance with the Company, Quality Manual and its governing regulations.
- Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices.
- Conduct qualification, verification, and validation activities for the production of medical devices.
- Analyze, troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
- Complete engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
- Design & develop manufacturing equipment in compliance with manufacturing safety (e.g., OSHA & EPA) principles.
- Design, procure, and fabricate tooling and fixtures.
- Participate in design control efforts related to risk analysis (FMEA) & design reviews.
- Source component and service suppliers; assess supplier capability and effectiveness.
- Train, develop, and/or provide work direction to operators and technicians.
- Participate in the identification, implementation, and management of production goals.
- Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
- Design and coordinate engineering tests and experiments. Analyze data, draw conclusions, and summarize test results. Communicate results to manager.
- Interfaces with product builders or extrusion technicians, production supervisors, and engineers in troubleshooting problems on the production floor.
- 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/process performance.
- Designing, developing, testing, and validating equipment and processes; analyzing and interpreting process models and recommending process improvements.
- Evaluating external process technologies.
- Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans.
- Participates in project planning and scheduling.
- Attends and contributes to product core team meetings.
- Performs responsibilities required by the Quality System and other duties as assigned or requested.
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