- Philips (Plymouth, MN)
- …a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... with the RA management. + Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure… more
- J&J Family of Companies (New Brighton, MN)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... personnel. **Requirements** + High School diploma or GED or 0-2 years' in a medical device environment or equivalent experience in a similar work environment. +… more
- Medtronic (Minneapolis, MN)
- … principles is essential + Practical knowledge of project management. + Medical Device Industry experience. + Familiarity with these regulations: FDA ... understanding of designs, documentation of compliance to requirements and timely, high- quality product launches that satisfy patient needs and reduce customer… more
- Abbott (St. Paul, MN)
- …of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971 + Prior medical device experience preferred. Apply Now (https://www.jobs.abbott/us/en) **Learn more about our ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Delta Air Lines, Inc. (Minneapolis, MN)
- …a broad spectrum of EUC technologies, including desktop virtualization, device management, security, application delivery, and end-user support, ensuring optimal ... intervention. + **Security and Compliance:** Implement and enforce policies for device and data security, ensuring compliance with organizational standards and… more
- Danaher Corporation (Chaska, MN)
- …to manage medium/large design changes and technology transfer projects in the Medical Device or Diagnostics regulatory environment, ensuring compliance with ISO ... experience leading multiple projects/a project manager + Prior experience in Medical Device manufacturing environments + Change Management Certification desired… more
- Abbott (Plymouth, MN)
- … experience with new product development + Minimum of 3 years quality engineering experience supporting disposable ablation catheter production + Minimum ... + Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971 + Prior medical device experience preferred. **What We Offer** At Abbott, you can have a… more
- Philips (Plymouth, MN)
- …You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software Design ... with quality , safety, and regulatory standards, while identifying and addressing engineering deficiencies to embed quality within the designs. + Leads the… more
- Medtronic (Mounds View, MN)
- …Responsible for serving as a contact between R&D and suppliers to develop complex medical device products. Responsible for the reduction and mitigation of risk, ... cross-functional groups and suppliers. Responsible for Product Validation and Supplier Quality to include technical aspects of projects. Utilize Design Reliability… more
- NTT America, Inc. (St. Paul, MN)
- …on mechanical infrastructure for new and improvement projects. + Provide engineering guidance for sales opportunities and customer projects. + Troubleshoot problems ... Standards. + Provides incident management and system operational guidance, engineering policies and procedures, maintenance, and equipment troubleshooting. + Serve… more