10 data engineer jobs found in Maple Grove, MN

Quality Technician/Engineer Job Description: We are seeking a Quality Technician/Engineer to support the process development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural heart implants and quality inspection processes, and understands GMP requirements for the manufacture of a sterile medical device. Responsibilities: Execute lab-based process development runs in a laboratory setting to develop tissue processing of bovine pericardium. Implement quality controls during process development to ensure tissue performance, biocompatibility, and repeatability. Establish tissue-specific manufacturing procedures, inspection criteria, and in-process controls. Develop and maintain relationships with testing vendors for ongoing testing and process development characterization. Maintain test schedules and coordinate sample drop-off and pickup. Review technical documentation, such as...

Job Title: Mechanical EngineerJob Description We are seeking a Mechanical Engineer with a strong background in new product development, particularly within regulated industries such as medical device design. This role requires a blend of technical expertise and project management skills to lead product design, development, and implementation efforts. Responsibilities Lead product design and development initiatives. Complete Design History File (DHF) document deliverables. Apply principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials. Design medical products and validate designs using methodologies and tools such as FEA, GD&T, and CFD. Collaborate with suppliers and manufacturing facilities to ensure designs are manufacturable. Identify and efficiently resolve technical problems and issues. Communicate effectively with clients for small scale programs. Research and analyze experimental data to...

Job Title: Process Development EngineerJob Description We are seeking a highly motivated Process Development Engineer to lead and support catheter development initiatives within our contract manufacturing operations. This role is critical to driving process innovation, equipment validation, and product quality in compliance with ISO standards. Responsibilities Lead process development activities for catheter manufacturing, including prototyping, scale-up, and transfer to production. Conduct IQ/OQ/PQ validations for manufacturing equipment and ensure compliance with regulatory standards. Develop and validate test methods to ensure product performance and reliability. Perform process characterizations using statistical tools and methodologies. Utilize Minitab for data analysis, DOE, SPC, and capability studies. Collaborate with cross-functional teams to optimize manufacturing processes and improve yield and efficiency. Support and...

Job Description: The Quality Engineer is responsible for developing new processes and products, validating new equipment and technology, assisting production with continuous improvement on the shop floor, managing customer complaints, and handling CAPA/NCR activities. This role also involves leading change requests with customers and ensuring compliance with ISO, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors (QAR). Responsibilities: Develop new processes and products and revise existing ones. Create and update project-specific quality plans, ensuring adherence to customer requirements. Work as part of a cross-functional team to develop methods to measure products to ensure they meet quality standards. Troubleshoot measurement methods and equipment to ensure accuracy and reliability. Lead validation of new products and technology (IQ, OQ, PQ) and act as QA lead for...

Quality Technician/Engineer Job Description: We are seeking a Quality Technician/Engineer to support the process development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural heart implants and quality inspection processes, and understands GMP requirements for the manufacture of a sterile medical device. Responsibilities: Execute lab-based process development runs in a laboratory setting to develop tissue processing of bovine pericardium. Implement quality controls during process development to ensure tissue performance, biocompatibility, and repeatability. Establish tissue-specific manufacturing procedures, inspection criteria, and in-process controls. Develop and maintain relationships with testing vendors for ongoing testing and process development characterization. Maintain test schedules and coordinate sample drop-off and pickup. Review technical documentation, such as...

Job Title: Senior Quality EngineerJob Description The Senior Manufacturing Quality Engineer is a key member of our innovative team working on cutting-edge technologies in the field of cardiology. The primary responsibility of this role is to ensure the design assurance of a heart valve and a delivery catheter system. This position requires a background in the medical device industry, particularly in cardiological devices, including implantable heart valves and transcatheter delivery systems, along with a strong understanding of regulations and standards such as 21 CFR 820. Responsibilities Lead the product development process including key design assurance activities, design reviews, verification and validation activities, development and validation of testing methods, management of product requirements, test case tracing, and risk management. Facilitate the transition of new product development into production. Conduct reviews and enhancements of Quality...

Design Quality Engineer Job Description: The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. This role involves close collaboration with various functions, including R&D and Product Development core teams, to ensure appropriate design controls are established and achievable. Additionally, the position supports process development, manufacturing-related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts. Responsibilities: Own the creation and implementation of all design control deliverables. Lead on-time Design Verification and Design Validation and support Process Validation IQ/OQ/PQ/PPQ planning and execution. Actively participate in and contribute to core team and customer-facing meetings. Drive the meaningful translation of user requirements into discrete, objective, measurable, verifiable, and traceable product requirements....

The Senior Mechanical Engineer will select technologies, methodologies and define requirements for individual projects; research and analyze data such as experimental data, customer design proposals, specifications, and documentation; direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications; resolve technical issues and problems; effectively communicate their work and status; and delegate work and leverage engineering technicians and designers. Responsibilities: Apply principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials. Design medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc. Evaluate mechanical and electromechanical systems and products by designing and conducting research programs. Lead and complete medical standard document deliverables. Identify and efficiently resolve...

Job Description: This position offers the opportunity to support process development and product commercialization throughout the global plant network. You will work cross-functionally to lead process development of complex technologies on new products, drive new business activities, and ensure efficient and effective transfer of products into production. This role is ideal for a highly motivated individual who can solve complex technical problems both independently and in a team setting. The environment is fast-paced and will require collaboration across multiple functions within a global company. Your technical skills, passion for innovation, and continuous improvement will be key in driving growth through efficient commercialization of new products. Responsibilities: Partner with R&D to develop design specifications, draft test methods, and drive material selection. Provide Design for Manufacturability (DFM) input to the engineering print package....

R&D Test Technician Job Description: The R&D Test Technician will support the engineering team in the hands-on build, assembly, testing, and troubleshooting of medical devices and associated fixtures. This role is critical to ensuring high-quality prototype builds, precise test execution, and reliable documentation in support of design verification, process validation, and product development activities. The ideal candidate is an experienced, detail-oriented technician who is comfortable working in a regulated medical device environment and can collaborate effectively with engineers, quality professionals, and manufacturing teams. Responsibilities: Build and assemble medical devices and associated fixtures. Perform testing and troubleshooting of prototypes. Ensure high-quality prototype builds and precise test execution. Document and support design verification and process validation activities. Collaborate with engineers, quality...