, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing... with all relevant medical device regulations and standards, such as FDA regulations, ISO 13485, and IEC 60601. Process improvement...
of a work product in Technical Process Areas associated with the ISO/IEC 15288. Perform systems engineering activities.../IEC 15288 processes. Assist in performing systems engineering activities in the ISO/IEC 15288 Agreement or Enterprise...
Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO... process improvement, transfer and sustainment of QMS processes, across Operations and R&D, to the Digital QMS platform...
leader, who drives the continuous improvement of innovation, quality, delivery, and productivity within the R&D organization... of IEC 60601 series standards Understanding of design for manufacturability and reliability, with full product life cycle...
: Maintenance and scope extension of all accreditations (e.g. ISO/IEC 17025), customer approvals and any other regulatory... qualification) in a scientific discipline. Experience of working in an ISO / IEC 17025 environment is a preferred. Medical device...
Maintenance and scope extension of all accreditations (e.g. ISO/IEC 17025), customer approvals and any other regulatory... qualification) in a scientific discipline. Experience of working in an ISO / IEC 17025 environment is a preferred. Medical device...
Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline... that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971. Strong understanding of system...
and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls... and IEC 62304 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts...
and testing required to obtain safety, EMC/wireless and similar certifications. Experience with the relevant UL, CSA, FCC, IEC... is differentiating. The engineer will participate in advising R&D teams on development practices, developing test plans encompassing...
the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In this vital role... collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D, to the Digital QMS...