3 software engineer jobs found in Arden Hills, MN

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). - Provide technical support for day-to-day manufacturing line operations, troubleshooting 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 root causes and...

Senior Quality Engineer Job Description: The Senior Quality Engineer is a top-level Quality Assurance Engineer position responsible for ensuring product quality. This role involves independently completing validation and qualification activities while ensuring customer quality needs are met through cross-departmental collaboration. The position will frequently interface with customers to complete new product and process validations, address product quality issues, and maintain customer relationships. Responsibilities: Plan and conduct analysis, design, testing, and integration to assure product or component quality. Perform engineering reviews of design and production documentation for compliance with requirements, including vendor and supplier quality manuals and company quality records. Apply statistical process control (SPC) or other appropriate methods to analyze data and evaluate current processes and changes, determining corrective actions if needed....

Job Description Insight Global is looking for a Senior Electrical Engineer to join a leading medical device manufacturing company's Cardiology team. This position supports complex R&D new product development projects for active implantable devices with minimal technical oversight. The role involves designing, developing, debugging, and testing electrical circuits and systems; creating protocols; executing design verification testing; and performing statistical analysis and documentation within the quality system. Responsibilities include analyzing requirements, investigating and selecting components, conducting exploratory testing, and preparing evaluation reports to meet regulatory standards. The engineer will utilize tools such as Accurev, JIRA, and Windchill for version control and defect tracking, while solving technical problems, recommending corrective actions, and proposing innovative solutions. Working independently or as part of a team, this individual ensures...