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Current Positions
R & D Mechanical
Conducts applied industrial research using scientific methodology, which is ultimately incorporated into a commercially viable medical device, or how an existing medical device is applied therapeutically. Conducts preclinical research, participates in clinical research. Represents the company as appropriate.
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Under limited supervision, designs and documents effective and efficient tools, fixtures, machines and equipment for the manufacture of Company products.
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Technical responsibilities for one or more cardiovascular devices.
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Interface with physicians to develop new product ideas and develop solutions to complex clinical issues.
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The Principal Engineer will work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Determines direction and adequacy of designs and test results and recommends changes.
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The Principal Engineer will work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Determines direction and adequacy of designs and test results and recommends changes.
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Senior R&D Mechanical Engineer with a proven track record of designing and developing a variety of medical devices or scientific instrumentation from concept through prototype and into production.
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Researches, plans, and designs mechanical parts and assemblies for ventilator and related equipment by performing the following duties.
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R & D Electronics / Software
Researches, develops, designs, and tests electrical components, equipment, and systems by performing the following duties.
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Researches, designs, and develops computer software for microprocessor systems for ventilators and related equipment.
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Manufacturing / Operations
Provide industrial engineering support to Operations Group.
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As part of new product development team, Design and develop manufacturing processes, tooling, and fixtures for new catheter and cable designs. Work closely with other manufacturing engineers to transfer new products to production.
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Responsible for developing, implementing, and validating processes and procedures to manufacture electromechanical and catheter-based medical devices in full compliance with the company’s quality system.
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Support Operations group through development and support of manufacturing equipment and processes in assembly of an implantable medical device.
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Assist with the formulation, manufacturing and testing of polyacrylamide electrophoresis (PAGE) gels, kits and reagents
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The Sr. Manufacturing Engineer is responsible for providing leadership and insight, as appropriate, into the supplier base toward quality improvement, cost reduction and new product development programs. This position ensures that supplier manufacturing processes deliver consistently high quality products to the company at competitive pricing throughout the product life cycle.
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Management
Responsible for implementation and maintenance of all aspects of quality system including complaints, CAPA, internal audits and document control.
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The Regulatory Manager will be responsible for managing the regulatory submissions associated with new and revised designs.
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Responsible for managing the processes of Supplier Control, Non-conforming Material, and Equipment Calibration and Maintenance. The manager will provide quality engineering support for these processes as well as for Design Control, Change Control, Manufacturing Support, CAPA and Software Validations associated with Quality System software implementations.
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Sales & Marketing
Searching for a Territorial Sales Manager living in the Bay Area
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Quality / Regulatory / Clinical Affairs
Responsible for coordinating and performing internal audits and inspections. Reports and manages Complaints and CAPA processes. Monitors, and improves device reporting and tracking/control systems.
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Provide pre-sale and post-sale customer education and clinical support of company products and their applications. Have total familiarity with the Device GMP Regulations and the companies’ Quality Systems requirements and assures that these are followed.
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Functions as a management representative for ISO and FDA. Resolve all conflicts between the quality program and any other policies, procedures or operation within the company and implement the necessary changes.
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The Quality Assurance Manager develops and maintains a system to assure that all products manufactured by the organization meets required specification and achieves superior quality and reliability levels.
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