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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.
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Supports new product development plans.
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Conducts applied industrial research using scientific and engineering methodology, which is ultimately incorporated into a commercially viable medical device, or how an existing medical device is applied therapeutically. Represents the company as appropriate.
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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
Develop analog and digital electronics for a new series of medical instruments and devices. Responsibilities will cover a wide range of hardware development.
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Support all operational aspects of electrical test processes used in manufacturing.
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The Analog Design Engineer is responsible for assisting in the electrical design and development of an implantable defibrillator.
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Assist in the design, development and evaluation of new circuits and systems.
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Researches, designs, and develops computer software for microprocessor systems for ventilators and related equipment.
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Manufacturing / Operations
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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As a working lead, provide guidance and leadership for the day to day activities to the subordinate staff. Also is the acting supervisor when the department head is out
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Assembles medical device components and electronic systems
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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. Apply Lean Six-Sigma concepts to reduce waste and maximize efficiency. Troubleshoot production issues. Work with vendors to drive cost reductions to existing components and assemblies.
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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. Apply Lean Six-Sigma concepts to reduce waste and maximize efficiency. Troubleshoot production issues. Work with vendors to drive cost reductions to existing components and assemblies.
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Management
Responsible for the management and supervision of Quality Assurance activities including Receiving Inspection, In-process Inspection, Final Release, Non-conforming material control and Supplier Control.
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Medical experience a plus. Call 949/340-2136 for details
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An ideal candidate in this role would have strong technical background in analog/digital electronics design, hands-on product development experience, and has successfully managed medical products through market adoption.
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Sales & Marketing
The Clinical Sales Support Specialist provides Clinical Sales Support to their designated regional territory. Will be responsible to perform in-service and train clinicians in the hospital and home care arena about ventilators. The Clinical Sales Support Specialist is responsible to provide Clinical support pre-purchase of product and on-going clinical support after the product is purchased.
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Must have spine experience. Call 949/340-2136 for details
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Quality / Regulatory / Clinical Affairs
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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Collaborates with the VP of Quality Assurance & Regulatory Affairs to ensure compliance with the corporate quality system that includes compliance with the QSR and applicable ISO Standards, providing support to product development for product assurance and reliability testing, risk analysis, internal and third-party audits.
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Support manufacturing and quality assurance groups to ensure quality product and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Class III Medical Devices.
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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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