- MicroVention, Inc. (Aliso Viejo, CA)
- …experience working in the medical device industry. 2. Knowledge of medical device document control requirements and practices. 3. Experience ... Good Documentation Practices (GDP) requirements. + Maintain paper and electronic training document files to current requirements as defined by the Quality System. +… more
- AbbVie (Pleasanton, CA)
- …assist in transfer methods to manufacturing. + Document ECO changes within the Document Control system. + Coordinate design tasks for other team members for ... a range of design concepts. + Prepare, present, and document designs at technical reviews. + Refine and develop...with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international… more
- AbbVie (Irvine, CA)
- …assist in transfer methods to manufacturing. + Document ECO changes within the Document Control system. + Coordinate design tasks for other team members for ... a range of design concepts. + Prepare, present, and document designs at technical reviews. + Refine and develop...with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international… more
- Abbott (Pleasanton, CA)
- …including but not limited to Management Review, Internal Audit, Audit Readiness, CAPA, Document Control , Training, Product Release, and others as needed. + Be ... action and accomplish goals. The Senior Manager, Software Design Control is responsible for managing a team of software...a Quality, Regulatory, or product development role in the medical device industry. + 5+ years' experience… more
- Ford Motor Company (Irvine, CA)
- …on Telematics will be responsible for complete end to end integration of Telematics Control Unit (TCU) and participate in the system level design activities for the ... electric vehicles. + Lead the design, integration and functional testing of Telematics Control Unit (TCU) + Characterize the cellular system by arranging the antenna… more
- Terumo Medical Corporation (Campbell, CA)
- …business unit, including device history record review and release, document control , training, receiving, incoming inspection, and final release testing. ... ensure consistent work and compliance with established processes. + ** Document Control :** Process document change...is required. + A minimum of 5 years in medical device or similar product design and/or… more
- J&J Family of Companies (Santa Clara, CA)
- …Hardware and Embedded Software Design, with a minimum of 8 years in the Medical Device industry. + Experience with Analog and Digital Circuit Design, schematic ... systems, source version control , Issue Tracking, and control electronics for use in medical devices...or other equivalent experience. + Working knowledge of applicable medical device regulations and standard such as… more
- Abbott (Pleasanton, CA)
- …** Medical device experience** + Experience working with an electronic document control system + Experience working with cross-functional teams in a ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Amgen (Thousand Oaks, CA)
- …construction, commissioning, and qualification + Experience with combination product or medical device design development and manufacturing + Knowledge and ... and coordination/execution of required NPI activities, which may include document preparation/revisions, change control management, manufacturing process...expertise in device design control , design transfer, and combination… more
- Actalent (Carlsbad, CA)
- …Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements. Assist in the implementation of the quality ... Management System, FDA 21 CFR Part 820 QSR, and medical device industry requirements. + Assist in...with Nonconformance Material Report (NCMR) processes. + Proficiency in document control . + Knowledge of Geometric Dimensioning… more
- Edwards Lifesciences (Irvine, CA)
- …to cardiovascular anatomy, pathology, and physiology + Substantial understanding of medical device regulatory requirements and documents, adverse events ... product development process. + Provide expertise and clinical insights on the device , procedure, and protocol throughout the product life cycle from early studies… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …of experience writing end-user software or hardware instructions. Experience in the medical device industry and working in a federally regulated environment ... control system (LSQM). + Manage all aspects of document development and assist in production release, including draft...bodies (FDA, IVDR, EUDR) and the European Union (EU Medical Device Regulation). + Deliver supporting documentation… more
- Veterans Affairs, Veterans Health Administration (Long Beach, CA)
- …oxygen devices and high flow delivery devices. The incumbent will monitor and document type of delivery device , effectiveness of delivery by pulse oximetry ... auscultation of the lung field and documentation of findings. Assesses and document the ventilatory status of the patient and provide assistance in determining… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …ISO 13485. IEC 60601 and IEC 62304 experience a plus. + Experience in medical device and/or regulated industry (required). + Experience with remediation efforts ... risks are not acceptable, lead efforts to identify and document risk control methods. + Support the...8+ years in a regulated industry, particularly within the medical device , bio-pharmaceutical, or biotechnology sectors, with… more
- General Atomics (San Diego, CA)
- …We currently have several exciting opportunities for a mid-level Instrumentation and Control (I&C) engineer as part of the Engineering and Projects team in ... supervision, is responsible for data acquisition and instrumentation hardware, control software, developing and implementing design specifications, implementing industrial… more
- Power Device Corp (Poway, CA)
- Software Engineer Sr- Space Department:Space Engineering Location:Poway , CA Power Device Corporation (PDC) is recognized as a world leader in the design and ... manufacture of high-reliability Power, Control , and Computer and related equipment solutions for the...to bring in new technical capability + Design, develop, document and test embedded software for space products +… more
- Envista Holdings Corporation (Pomona, CA)
- …This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device requirements) are with respect to such process as CAPA, ... FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR, MDSAP and Canadian Medical Device and other regulatory and/or national and international standards as… more
- Actalent (Irvine, CA)
- …for incorporating in disposable products and developing test equipment. + Experience in medical device or other highly regulated industry Additional Skills & ... include limited project management duties. Responsibilities + Design, fabricate, document , deploy and maintain electronic systems and fixtures for...Qualifications + Medical device experience + Test equipment experience… more
- TEKsystems (San Diego, CA)
- …principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical ... Management tool and traceability Preferred skills (not required) 1. Experience with medical device software development. 2. Familiarity with CGM technology. 3.… more
- Abbott (Alameda, CA)
- …and regulatory conformance issues. + Ensure Quality Records required for DHF, DMR, Document Control and Training are appropriately implemented as it relates to ... They help ensure the consistency of product through strong document and labelling control , training, software, test...the Quality or Compliance and Technical discipline, in the Medical Device Industry or other FDA regulated… more