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Company: US Tech Solutions
Location: San Clemente
Posted on: November 16, 2022

Job Description:

Job DescriptionThe Systems Engineer will support the product development team initiatives related to the hemodynamic monitoring platform. The Systems Engineer will have project responsibilities, including validation and verification activities, management of system level documentation, risk analysis, trace matrices, and other regulatory compliance activities.
Essential Duties & Responsibilities
--- Ensure product user needs and system and subsystem requirements are clearly defined, testable and well documented.
--- Work with development team on risk analysis re-baselining effort.
--- Ensure User FMEA, Design FMEA and Process FMEA documentation is compliant with updated company processes and procedures.
--- Perform data collection and analysis related to the system performance as needed.
--- Produce / review test protocols and reports in support of regulatory submissions
--- Support FDA submission activities ensuring regulatory compliance.
--- Coordinate with all members of the Product Development Team including, project management, quality, regulatory and manufacturing.
Knowledge, Skills & Qualifications
--- Knowledge of system identification, modeling, analysis, architecture, integration and testing
--- Strong analytical and problem-solving skills
--- Solid understanding and experience in Design Control, Risk Management and Risk Analysis including FMEAs
--- Experience in system validations, reliability testing and usability studies
--- Good knowledge of: 21 CFR Part 820, ISO 13485 and ISO 14971
--- Experience with Design History Files, Technical Files and Device Master Record
--- Ability to fully support R&D group and Quality department by building quality into all aspects of work and by maintaining compliance to all standard operating procedures
--- Able to work quickly and effectively under pressure and to efficiently deal with multiple priorities simultaneously
--- Strong ability to work with others to expedite project completion
--- Proficient in Excel, Word, and Outlook
--- Experience in project leadership
Education and Experience
--- Bachelor's degree in Electrical, Biomedical, Mechanical or Chemical Engineering, or a related field from an accredited college or university.
--- Minimum 4 years of experience in electromechanical medical device (510k/PMA products) development or equivalent regulated industry
--- Experience in hClientard analysis and failure mode and effect analysis techniques is required.
--- Experience in UDI and product labeling activities is desirable
--- Experience in new product development with successful design from concept to commercialization is preferred.: 21-21887 : San Clemente, CA:

Keywords: US Tech Solutions, San Clemente , Engineer-Systems, Other , San Clemente, California

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