- Kelly Services (Washington, DC)
- …for new and/or on-going in vitro diagnostic clinical evaluations.** Must have** ** IVD monitoring experience** **clearly documented on resume or your application will ... + Minimum of 5 years of experience with **monitoring In Vitro Diagnostic ( IVD ) products or medical devices.** + **Experience working directly for a sponsor company… more
- Nanobiosym, Inc. (Cambridge, MA)
- …or related field + Minimum of 7 years of relevant industry experience and IVD assay development + In depth knowledge and hands on experience with qPCR, sequencing ... and standard molecular biology techniques + Demonstrated technical, managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated experience and… more
- Danaher Corporation (Boulder, CO)
- …Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize ... that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher. Together,… more
- Danaher Corporation (Golden, CO)
- …Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize ... that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher. Together,… more
- Amgen (Washington, DC)
- …you will report to the Senior Manager, of Precision Medicine and In-Vitro Diagnostics ( IVD ) within R&D Quality. This role supports the use of In-Vitro Diagnostics ( ... IVD ), including Companion Diagnostics (CDx), within Amgen's global clinical...implementation of a proactive and risk-based Quality strategy for IVD medical devices , including collaborations with diagnostic partners… more
- TE Connectivity (Boston, MA)
- …The Americas Sales/Account Manager (SAM) is responsible for promoting the TE IVD Business Unit products and services. This position is responsible for developing ... delivers profitable growth, by leveraging the full range of IVD Services, Products and Core Competencies. The Sales/Account Manager...objectives in our key segments of microfluidic consumables including IVD Point of Care / Point of Need, Cell… more
- Caris Life Sciences (Phoenix, AZ)
- …the implementation of manufacturing operations in a hybrid (diagnostic/ IVD and clinical/CLIA/CAP/LDT) laboratory environment. **Job Responsibilities** Process ... such as DHR (Device History Record or batch records) for new medical device/ IVD products. + Coordinate the training of Laboratory Ops personnel, Quality Engineers… more
- Danaher Corporation (Sunnyvale, CA)
- …scientist and is responsible for early development of in vitro diagnostic ( IVD ) assays and/or product development in an FDA-QSR and ISO13485 compliant organization. ... will have the opportunity to: + Develop infectious disease IVD tests based on design input requirements by following...applying problem-solving skills and strategies for the development of IVD tests on the GeneXpert platform. + Design and… more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- ThermoFisher Scientific (Middletown, VA)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- Epic Sciences (San Diego, CA)
- …computer vision, data analytics and experience in developing and launching IVD software products are required. ELEMENTS: Education/Experience: + Bachelor's degree in ... of software platforms and data-driven solutions in a regulated environment (eg, IVD products). + Experience in designing and implementing algorithm pipelines and… more
- ThermoFisher Scientific (Austin, TX)
- …a broad understanding of molecular biology, and an understanding of regulated product development (CE- IVD and IVD ). **What will you do?** You will: + Design and ... and cancer biology will make you a stronger candidate. + Experience in IVD product development is a plus. + Experience in automated nucleic acid purification… more
- WTW (Atlanta, GA)
- …and handle a book of business to ensure consistency and credibility among IVD clients. + **Client Service Delivery:** + Oversee and drive client service delivery ... + Coordinate events and conferences for the Industry Vertical Division ( IVD ) and structure Capstone engagements with Broking Leadership. + **Client Relationship… more
- Danaher Corporation (Miami, FL)
- …reliability concepts in the design and development of our next generation Hematology IVD platforms, as well as provide support for continuing improvement projects on ... in: + Prior working experience in an FDA-regulated environment, especially in IVD industry + Prior working experience with requirements of ISO 14971, Application… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …expected to manage and deliver a portfolio of diagnostic projects (CDx, IVD , etc.) within Regeneron's drug development pipeline in close partnership with Diagnostic ... Strategy Leads and IVD Regulatory. This role includes portfolio management, program/project management...close collaboration to CDx Strategy Leads, clinical laboratory managers, IVD regulatory and others as required + Track and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …study conduct, sample management testing to launch) in collaboration with partners/ IVD Sponsors and central testing laboratories to support early and late-stage ... all of the relevant inputs + Develop strong relationships partnerships with IVD partners and testing laboratories + Oversee operational aspects of CDx clinical… more
- ThermoFisher Scientific (San Jose, CA)
- …Quality Specialist is responsible for processing and closing all medical device/ IVD , product safety complaints ensuring that all required documentation is maintained ... Initiate, update, and optimally close all product safety, medical device/ IVD complaints. + Lead all CAPA program activities including...+ 2+ years as a QA professional (in a CE/ IVD or FDA supervised company preferred). + Experience in… more
- TE Connectivity (Parker, CO)
- …strategy and road map of delivery for your site in line with the IVD business strategy ensuring alignment throughout the facility to goals and deliverables * Site ... focuses on continuous improvement * Engage with the other IVD Ops managers globally to ensure standardization of process...to ensure standardization of process and approach across the IVD Operations network * Manage and optimize resources to… more
- Kelly Services (Sunnyvale, CA)
- …of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products. + Knowledge of US- IVD , CE-IVDD, CE-IVDR ... governance for IVD diagnostic products. + Familiarity with QMS, ISO standards, including ISO 13485. **Preferred Requirements:** + Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications. + Experience in project management. As… more
- Hologic (San Diego, CA)
- …clinical research. + Experience in an in vitro diagnostic device ( IVD ) environment is highly preferred.Strong knowledge of relevant international clinical compliance ... and in particular US and EU regulations relevant to Medical Device and IVD clinical trials and Quality Systems, including Good Clinical Practices and Good… more