The Service Process Engineer will manage the day-to-day operations, and long-term process improvements, for the preventive maintenance and repair of the GENOSYL DS console.
The role includes developing, implementing, and scaling of service processes and methods, optimizing current service processes and methods, and developing service process strategies to optimize the servicing of GENOSYL DS consoles.
This role will need to effectively work with VERO Engineering and R&D, Operations, Quality, Regulatory, Supply Chain, and Post Market Surveillance teams. Key Performance Indicators for this position include attainment of project targets, scaling to reach target monthly volumes, and optimization of the service process to achieve target console inventory positions.
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Manage projects to establish and scale the maintenance process(es) at Vero.
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Create and maintain detailed process documentation, including standard operating procedures (SOPs) and work instructions.
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Train technicians on process documentation and servicing methods to ensure high-quality standards with a focus on producing safe and effective medical devices.
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Participate in the development, selection, and validation of manufacturing equipment, tooling, and fixtures to meet production requirements.
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Analyze and improve existing manufacturing processes to enhance efficiency, product quality, safety, and to reduce maintenance costs.
- Conduct product and component failure investigations; compile quality data and prepare reports to communicate problem/resolution/progress.
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Prepare and present service reports with statistical metrics to make data driven decisions
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Coordinate with Vero Supply Chain to understand inventory positions and servicing needs.
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Coordinate and perform Engineering/R&D GENOSYL DS console repair and/or rework to ensure continued console hardware supply to engineering teams.
- Collaborate with R&D and other teams to design, develop, and validate new manufacturing processes.
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Work with Vero Engineering/R&D to define and evaluate preventive maintenance schedules and requirements for the GENOSYL DS console.
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Stop or postpone manufacturing or servicing of products if quality and/or regulatory concerns have been identified or suspected, and coordinate resolution.
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Work with senior management to develop servicing strategies to ensure execution of Vero’s strategic objectives.
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Performs other related duties as assigned by management.
- Bachelor’s degree in an engineering or similar technical field.
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Two to four years related experience or equivalent. Experience in a regulated industry preferred.
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Desire to work in a hands-on environment.
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Commitment to excellence and high standards.
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Excellent written and oral communication skills.
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Experience with SolidWorks or similar 3D modeling software.
- Basic competence in duties and tasks.
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Strong organizational, problem-solving, and analytical skills.
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Ability to manage priorities and workflow.
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Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
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Acute attention to detail.
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Demonstrated ability to plan and organize projects.
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Proven ability to handle multiple projects and meet deadlines.
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Good judgement with the ability to make timely and sound decisions.
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Creative, flexible, and innovative team player.
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Good knowledge of data collection, data analysis, evaluation, and scientific method.
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Working knowledge of LEAN principles preferred.
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Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.