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Aerotek Systems Engineer in San Clemente, California

Description:

This role will be working on the critical care line. The specific product is called Cogent, which is on of the legacy products involved with catheters, etc.

Technical skills:

• Electronics/software background preferred, could be open to someone with mechanical that has exposure to hardware

• Strong FDA requirement experience

• Requirements development

• Testing and integration

• Working closely with quality group

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

Knowledge, Skills & Qualifications

• 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

Skills:

medical device, systems engineering, Electrical, Electrical engineering, Hardware

Top Skills Details:

  • Systems Engineering

  • Medical Device

  • Strong electronics hardware knowledge

  • some mixture of hardware and software

Additional Skills & Qualifications:

  • 7-10 years of experience

N2H:

  • strong hardware medical device knowledge in consumables

Experience Level:

Expert Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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