3 jobs found in Arden Hills, MN

Job Description The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. Additionally, the engineer supports daily manufacturing operations in a sustaining role, providing technical expertise to resolve issues and maintain production efficiency. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Responsibilities Provide technical support for day-to-day manufacturing line operations, troucleshooting equipment and process issues. Implement and lead continuous improvement projects to enhance productivity, quality, and cost-effectiveness. Lead process validation activities (IQ/OQ/PQ) in compliance with regulatory requirements. Manage line transfer projects, ensuring smooth transition and qualification of equipment and processes. Apply structured problem-solving methodologies (e.g., 5 Whys, Fishbone, DMAIC) to...

Job Description This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Responsibilities ESSENTIAL FUNCTIONS: Support R&D team to design and test catheters and delivery systems Develop concepts, designs and details for machines, tools and fixtures. Support includes overall design, design for manufacturing, test method development, and product verification and validation testing Lead technical discussion and decision making with cross functional team....

Job Description The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. Additionally, the engineer supports daily manufacturing operations in a sustaining role, providing technical expertise to resolve issues and maintain production efficiency. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Responsibilities Provide technical support for day-to-day manufacturing line operations, troucleshooting equipment and process issues. Implement and lead continuous improvement projects to enhance productivity, quality, and cost-effectiveness. Lead process validation activities (IQ/OQ/PQ) in compliance with regulatory requirements. Manage line transfer projects, ensuring smooth transition and qualification of equipment and processes. Apply structured problem-solving methodologies (e.g., 5 Whys, Fishbone, DMAIC) to identify...