- Medtronic (Fridley, MN)
- …+ Experience working in cross-functional and team environments + Experience working in FDA regulated and/or medical device environment + Experience ... in the definition, design, development, and testing of complex medical device systems within the Neuromodulation Operating...FDA 21CFR820.30 for Class I, II and III medical systems + Experience planning and providing guidance on… more
- Medtronic (Mounds View, MN)
- …profile_ + Bachelor's degree in a technical discipline + Minimum 2 years of medical device , engineering, quality or regulatory experience with Bachelor's ... limited to 30-day, Annual Report, 510(k). + Experience with FDA requirements, , Medical Device ...14971, ISO 13485, and other global regulatory requirements and quality standards Supporting device submissions + Strong… more
- Stryker (Minneapolis, MN)
- …required CERs, and annual updates. + Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and ... management software + Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and… more
- Insight Global (Maple Grove, MN)
- …preferred. . Minimum of 5 years of experience in design assurance within the medical device industry. . In-depth understanding of design control and risk ... role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll...management principles. . Proven experience with FDA , ISO, and IEC regulations and standards. . Proficient… 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 ... is hiring for a **Sr R&D Engineer - Shockwave Medical ** to join our team located in **New Brighton,...+ Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other… more
- Abbott (St. Paul, MN)
- …necessary detail. + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are ... device regulations, or with EU and other international medical device regulations and submissions. + Must...+ Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and… more
- Actalent (Minneapolis, MN)
- …product development initiatives for disposable medical devices. + Ensure compliance with FDA Design Controls and ISO Quality Management Systems. + Apply risk ... medical devices. The role requires expertise in medical device design, focusing on Class II...Six Sigma (DFSS) is highly desirable. + Experience with FDA Design Controls and ISO Quality Management… more
- ManpowerGroup (Plymouth, MN)
- …that consistently applies microbiological concepts to the manufacturing process of a medical device and understands and develops process monitoring/metrics to ... maintain microbiological quality of the final device **.** *...**Qualifications:** Bachelors degree with 5+ years of experience with Medical device /pharmaceutical, or related industry with work… more
- Abbott (Plymouth, MN)
- …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Minnetonka, MN)
- …+ Minimum 2 years In a high-volume, multi-product manufacturing environment, preferably in the medical device industry + Ability to learn, train, and follow good ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more