- Actalent (Chicago, IL)
- Job Title: Engineering Lead - EU MDR Remediation Job Description We are seeking a skilled and proactive Engineering Lead to support a long-term ... remediation activities to ensure alignment with EU MDR requirements. In Phase 2, the Engineering ... engineering remediation of technical files to meet EU MDR standards. + Lead … more
- Philips (Chicago, IL)
- …and strategy for global product registrations (including 510(k), CE Marking under MDD/ EU MDR , Technical Files), and oversee worldwide product submissions and ... etc. in Medical Devices Industry or equivalent. Experience authoring submissions (510k, EU Tech Files, etc.) required. Experience with sustaining and new product… more
- Knowles Precision Devices (Itasca, IL)
- … engineering . Strong knowledge of: + Medical device regulations (FDA, ISO 13485, EU MDR ) + Validation protocols (IQ/OQ/PQ) + CAD tools (eg, SolidWorks, Creo) ... Staff Advanced Manufacturing Engineer (AME) - MedTech Department: Advance Manufacturing Engineering Employment Type: Full Time Location: Itasca, IL Reporting To:… more
- Danaher Corporation (Deer Park, IL)
- …indicators (KPIs) to ensure training programs remain current and compliant with FDA, EU MDR /IVDR, and ISO 13485 standards. + Support the development and ... skills, capacity, and succession plans with business needs. + Lead the team responsible for resolving complex technical issues...requirements of the job include: + Bachelor's degree in engineering or scientific discipline + 5+ years of experience… more
- Danaher Corporation (Richmond, IL)
- …a medical device quality system in compliance with US FDA, ISO 13485 and EU MDR /IVDR regulations + Proven experience in developing and implementing mining tools ... of the job include: + Bachelor's degree or equivalent advanced degree in engineering , science, medical, or technical field and 5+ years' experience with increasing… more
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