I have an excited Direct Hire opportunity for an Embedded Firmware Engineer with a Client located in Irvine, CA who is a vertically integrated high precision cross-industry contract manufacturer with off the shelf product solutions and unparalleled engineering capabilities to get you to market faster.
Works with and across the various disciplines of the engineering team, machine shop personnel, and assembly floor personnel for project realization, manufacturability, inspection, and assembly of product. One of the primary functions of the position is to create, develop, and establish cost effective processes and procedures for manufacturability, inspection, and assembly to reduce cost and improve fabrication methods that meet the product specifications and requirements.
- Collaborate with other engineers on the strategy for testing application and control software.
- Analyzes application-specific software and performs ambiguity reviews of business requirements and technical functional specification documents.
- Writes thorough test plans/test protocols, test cases, test scripts, and test scenarios.
- Execute test protocols, test cases, test scripts and scenarios and log/follow-up on defects.
- Write, execute and document test protocols and report results.
- Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).
- Design and Implement appropriate test protocols, test harnesses and test automation tools.
- Participate in product design and requirements reviews and evaluate requirements for testability.
- Responsible for assuring projects meet customer expectations, and regulatory requirements.
- Work with other engineers to help drive testability into the product.
SKILLS AND QUALIFICATIONS:
- BS in Engineering, Science or equivalent technical degree is required.
- 3-5 years of experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Must be proficient in C language. Familiarity with other languages such as C++, Python or Java is desirable but not necessary.
- Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x, ISO 13485.
- Experience with design controls for medical devices Title 21 CFR 820 and ISO 13485 is required.
- Experience with Risk Management ISO 14971 is required.
- Good working knowledge of ARM Assembly language or similar
- Experience with Code Composer Studio, Eclipse, or MPLAB IDEs is highly desirable,
- Must be comfortable using Emulators, Power Supply, Oscilloscope, and function generators
- Familiarity with different Micro-controllers is highly desirable.
- Familiarity with SPI, IIC, UART protocols is highly desirable.
- Experienced with the design and development of small electromechanical systems/devices is preferred.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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