- Actalent (Minneapolis, MN)
- …in Engineering or related field. + Minimum 4 years of experience in the medical device industry. + Strong understanding of test method development and ... balloons, catheters, and fluid-based testing. + Experience with ASTM standards relevant to medical devices. + Knowledge of regulatory requirements ( FDA , EU MDR).… more
- Fujifilm (St. Paul, MN)
- …and procedures. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard ... Knowledge Base articles. + Maintains an expert working knowledge of current medical imaging products and related technologies. + Engineers must have the ability… more
- Danaher Corporation (Chaska, MN)
- …be a plus if you also possess previous experience in: + Experience in the FDA -regulated diagnostics or medical device industry. + Exposure to the Danaher ... of enterprise AI and automation solutions that enhance workflows across Quality , Regulatory, and Clinical Affairs (QRC). This role blends project management,… more
- Danaher Corporation (New Brighton, MN)
- …It would be a plus if you also possess previous experience in: + Experience in Medical Device , IVD or FDA /EUMDR regulated industry. + Working knowledge on ... Process Engineer is responsible for Driving continuous improvement activities in quality , cycle time, yields and equipment availability by conducting validations of… more
- Abbott (Plymouth, MN)
- …to detail. + Ability to maintain regular and predictable attendance. + Experience in Medical Device or similar field preferred. **Learn more about our health and ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Fujifilm (St. Paul, MN)
- …and procedures. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard ... the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job… more
- Actalent (Burnsville, MN)
- …Engineering is a plus. * Five or more years of experience, preferable in the medical device field, in the discipline of systems engineering. * Experience with ... systems and system architecture and its associated documentation per established quality system procedures. You will work with multi-disciplinary teams to meet… more
- Grifols Shared Services North America, Inc (Minneapolis, MN)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides regulatory expertise… more
- United Therapeutics (Eden Prairie, MN)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... ), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans… more