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: 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: 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
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: Performs operations required for production assembly for medical device
manufacturing by executing the following duties.
- Executes sequenced procedures in all aspects of assembly, testing and final packaging including verifying component part numbers.
- Responsible for personal safety, product quality, and meeting specified work standards, following applicable procedures and guidelines.
- Support Manufacturing and Quality in assembly and/or inspection of plastic components.
- Recommend and implement changes to and/or modify fixturing and equipment to improve performance.
- Operate related equipment; conducts tests and reports data in prescribed format.
- Ability to use measuring devices, hand tools, jigs, fixtures
- Perform any other duties assigned by the supervisor.
- The Company reserves the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs. … read more
Summary: Responsible for performing the physical and administrative tasks involved in the storing, counting and distributing of materials, parts, supplies and equipment. Assists with purchasing tasks. Packages, receives, ships and moves materials through warehouse process. … read more
Summary: Provides technical support in development of assembly and packaging equipment and processes for medical device manufacturing. Executes sequenced procedures in all aspects of assembly, testing and final packaging, including verifying component part numbers. … read more
Regulatory & Quality
Summary: Plans and conducts activities concerned with the quality assurance of the OpitScanner device(s) and Disposable Cartridge. Directly responsible for all product test protocols and reports related to new product development and used to support regulatory submissions. … 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: Responsible for technology assessment and choice for implementation of
approved projects. Leadership of team that develops design and supports improvements
to the OptiScanner system. … read more
Summary: Designs and develops various electronic, electro-mechanical and electro-optical systems including digital and analog design, motor controls, sensors, and power management. This is a highly visible position as the principal EE in the company. … read more
Summary: The Mechatronics/Automation Engineer is responsible for supporting development of new R&D and manufacturing equipment, manufacturing processes, and QA test systems. They are expected to be experienced in the integration of electrical systems, software (including PLC, Arduino, and/or Windows-based programs), and mechanical systems. … read more
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Marketing & Sales
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