- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical ...with 9+ years of experience, preferably in areas of medical devices, engineering , or quality assurance.Strong knowledge… more
- Cytiva (Miami, FL)
- …3-5 years of experience in a process engineering or project engineering role, preferably in healthcare manufacturing or medical device production.2+ ... in a regulated environment. The ideal candidate will have experience in process engineering , project management, and a strong understanding of healthcare… more
- Raytheon (Tucson, AZ)
- … device drivers for bare-metal and/or OS applications.Experience leading engineering teams in delivering systems (of various size) involving the integration ... We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's… more
- Raytheon (Mckinney, TX)
- …We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's ... tough, meaningful problems that create a safer, more secure world. Tool Engineering is a career field that specializes in designing custom mechanical solutions… more
- Cytiva (Miami, FL)
- …Quality Engineering , or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated manufacturing ... & Advocacy: Collaborate with site and global leadership to address process changes, advocate for site-specific needs, and drive customer-centric solutions during… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent ... discovery to delivery. What you will do:Supplier qualification, including supplier process qualification (SPQ) for Type I (critical) supplier.Manage the supplier… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949#LI-OnsiteJoin our ... from discovery to delivery.What you will do:Supplier qualification, including supplier process qualification (SPQ) for Type I (critical) supplier.Manage the supplier… more
- Raytheon (Andover, MA)
- …We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's ... initiatives to go above and beyondRelentlessly interact with a team of process engineers, technology owners, and project leadsProduce key reliability metrics such as… more
- Cytiva (Miami, FL)
- …of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis and CAPA initiatives, ensuring… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other ... Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product documentation, inclusive of Design History, Product, Process… more
- dsm-firmenich (Exton, PA)
- …+ 3-5+ years experience as engineer preferably in process safety engineering , chemical operations, medical device , chemical operations, or associated ... ** Process Safety Engineer** **Wayne, PA/Exton, PA** The ...equipment. Prepare documentation to provide sufficient information for Project Engineering for detailed specifications for cost estimates and construction.… more
- Global Foundries (Malta, NY)
- …Preferred Qualifications: + MS or Ph.D. preferred + Prior experience in Nonvolatile memory: device engineering or process integration + Prior experience in ... Test, Integration and Process Modules to implement fast and cost-effective device improvements. + Support customer engineering to fully meet external… more
- Global Foundries (Malta, NY)
- …of device performance, designing the device , and working closely with process / integration engineering team on device fabrication using state of ... www.gf.com . Summary of Role: As a silicon photonics device engineer, you will be working on the development...in relevant field. Degree must be in Photonics, Electrical Engineering , Materials Science, Solid State Physics, or other relevant… more
- Lilly (Indianapolis, IN)
- …DOE's, GR&R's or process capability studies. + Previous drug delivery, medical device or pharmaceutical industry experience. + Experience working with ... /equipment design and development. + Implement standards and best practices for process engineering studies. Ensure appropriate level of quality in technical… more
- Merck (Rahway, NJ)
- …21 CFR Part 820, ISO 13485, ISO 14971 etc.) and industry standards related to medical device manufacturing is a plus. + Prior experience in glass container ... **Job Description** As a Senior Engineer in Device Design and Process Development group,...handling/assembly and complex medical device manufacturing (molding and assembly) is… more
- Amgen (Cambridge, MA)
- …transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** Let's ... In support of Amgen's mission to serve patients, the Device Engineering group at Amgen is a...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Director, Medical Device Safety Specialist in our Cambridge, MA office. At Takeda, we are ... vital contributor to our inspiring, bold mission. **OBJECTIVES:** The Medical Device Safety Specialist (Associate Director) ...Engineering . + Minimum of 5 years' experience in device safety or device quality assurance roles… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the global ... on-market medical devices including Software as a Medical Device (SaMD) and Software in a... software & mobile apps. + Drive change management process for device software / mobile app… more
- Pentax Medical (Montvale, NJ)
- … community. Position Opening: Senior Quality Engineer Why JOIN Us? We are an established medical device leader that is preparing for high growth. This means that ... Time Off and Holiday policy. Want More INFO? The Medical Device , Senior Quality Engineer will lead...quality improvement, remediation initiatives, and facilitate the change management process within the PENTAX Medical facility. This… more
- Eurofins (Boston, MA)
- …building a strategic vision and team to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality ... organization as a leader in consulting services for the medical device testing industry. + Define and...including US FDA 510(k), De Novo, PMA, and Breakthrough Device submissions. + Safety and Engineering Consulting:… more
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