Overview The R&D Manager, Capital Equipment will be responsible for overseeing R&D project team(s) in the execution... and business needs are appropriately addressed. Technical responsibility for all R&D activities assigned. Identifying new vendors...
for QA-related R&D activities from research through product launch. This position ensures that design controls and risk... of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality...
plans, operation and maintenance SOPs. · Supporting lab R&D team with mechanical design of custom laboratory apparatus... requirements. Understanding of controls engineering, PLC/PAC controllers and IEC 6113103 languages (ladder, FBD, structured text...
+ years industry experience Quality Assurance, R&D, or Regulatory Affairs in Medical Device or Pharmaceutical Industries.... Experience with Medical Device Quality Systems (21 CFR 820, ISO-13485, and EU MDR) Strong familiarity with ISO-14971 and IEC...
, 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...
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...
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...