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Senior Requirements HW/SW Systems Engineer

Company: Kforce Technology
Location: San Clemente
Posted on: January 13, 2022

Job Description:

RESPONSIBILITIES:Kforce is seeking a Senior Requirements HW/SW Systems Engineer in San Clemente, CA. Summary: The Senior Requirements HW/SW Systems Engineer is a technical focal point role having overall ownership of new product system performance for an Invasive Monitoring System. The Senior Requirements HW/SW Systems Engineer will have project responsibilities but may also assume a supervisory role of Design Engineer, and Engineering Laboratory Technicians. Essential Duties & Responsibilities: Technical focal point role having overall ownership of new product system performance for Invasive Monitoring Ensure product user requirements are clearly defined, testable and well documented Develop design requirements, concept builds and support transfer to manufacturing plans Ensure successful completion of system integration and validation Coordinate technical activities on the system between all contributing disciplines Partner with user and marketing to develop a complete understanding of the clinical intended use and its application in the real-world environment Write engineering performance specifications Develop basic models and test setups for system integration, troubleshooting and validation Perform data collection and analysis related to the system performance Produce test protocols and reports in support of regulatory submissions Coordinate with all members of the Product Development Team including, project management, quality, regulatory, manufacturing, purchasing and finance Job Requirements:REQUIREMENTS: Bachelor's degree in Electrical, Biomedical, Mechanical or Chemical Engineering, or a related field from an accredited college or university; Master's degree preferred Minimum 7 years of experience in electromechanical medical device (510k/PMA products) development or equivalent regulated industry Experience in new product development with successful design from concept to commercialization is required Experience in oximetry and catheter design preferred Experience in rapid product development, system development and integration, creative design, hands-on prototyping and troubleshooting, process development, design for manufacturing, and project management Knowledge of system identification, modeling, analysis, architecture, integration, and testing Strong ability to work with others and expedite project completion, and experience in project leadership Strong foundation in the development of complex medical devices 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 Strong analytical and problem-solving skills Able to work quickly and effectively under pressure and to efficiently deal with multiple priorities simultaneously Proficient in Excel, Word, and Outlook Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Keywords: Kforce Technology, San Clemente , Senior Requirements HW/SW Systems Engineer, Accounting, Auditing , San Clemente, California

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