OptiScan Biomedical is a growing medical device company located in Hayward, CA. We have developed an innovative monitoring platform for use in hospital intensive care units (ICUs) to support clinicians in detecting changes more rapidly in critically ill patients, enabling more timely intervention. The OptiScanner® platform is presently focused on delivering automated bedside glucose monitoring to inform clinicians’ decision-making and maintain a user-defined target glucose range.
We’re looking for dreamers, believers and builders.
Summary: This position is directly responsible for ensuring all manufacturing processes are scalable and required capacity is available to support commercial volume levels at established COGS target and with no degradation to product quality (yields). This includes ensuring an adequate capacity is in place for both internal and supplier processes. This position will also serve as the manufacturing point person for new product development projects led by R&D. This position will work closely with project members to ensure products are adequately designed for manufacturability. This position will serve as department head of Manufacturing Engineering- Cartridges and provide leadership and guidance to department personnel. The Senior Manager will be responsible for the department’s budget including capital equipment planning as it relates to manufacturing improvements and capacity … read more
Summary: Responsible for maintaining and supporting production needs on a daily basis. Develops and executes process validation plans (IQ, OQ, PQ), protocols and reports. Responsible for maintaining the “Process Failure Mode and Effects Analysis” (PFMEA) document for the products. Works concurrently with R&D and external vendors to design and develop manufacturing processes and equipment. As required, develops and maintains Process Flow Diagrams detailing production flow, process and tool drawings, Device Master Record Index (DMRI), Process Routers, Bills of Materials, Work and Inspection Instructions. Train production operators / product builders according to the work instructions. Develops and implements measures that improve product quality (yield improvement, complaint reduction) and drive cost savings (labor, material and overhead) … read more
Summary: The Clinical Research Manager will be responsible for developing and implementing clinical strategies, clinical trials, and post market studies effectively while aligning regulatory and business needs. The Clinical Research Manager collaborates with cross-functional teams, external clinical suppliers / vendors, and external key stakeholders such as hospitals, clinicians and government agencies, to ensure effective planning and execution of clinical trials. … read more
Summary: Develops and implements measures that improve product quality (yield improvement, complaint reduction) improve product reliability and cost savings product and process changes influencing labor, material and overhead costs. Responsible for developing and executing process validation (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ) plans, protocols and reports. Participates in the creation and maintenance of a Process Failure Mode and Effects Analysis (PFMEA). As required, develops and maintains Process Flow Diagrams detailing production flow, process and tool drawings, Device Master Record Index (DMRI), Process Routers, Bills of Materials, Work and Inspection Instructions. Coordinate with R&D in developing reliable and repeatable manufacturing processes. … read more
Summary: Designs and analyzes electro-mechanical systems, fixtures, equipment and packaging. Designs and analyzes disposable components . Creates and modifies detailed drawings using CAD hardware and software. … read more
Summary: Responsible for supporting non-conforming product, failure investigations, environmental monitoring assessment and tracking, corrective and preventive actions, complaint handling, technical & manufacturing engineering support for all Quality Assurance functions associated with the products of this company. … read more