Bio-Rad Laboratories has an immediate need for a Systems Engineer for our Benicia, CA location. This is a critical position in our Clinical Diagnostics Group supporting the successful development of cutting-edge diagnostics instrumentation.
You'll work as the Subject Matter Expert on all Systems Engineering-related matters from concept through commercialization including,
FMEAs and Risk Management
Drive alignment between subsystem plans and design input requirements
Verification and Validation
You'll also be the team lead and be able to assign tasks accordingly. You'll work closely with your manager to increase the technical proficiency of the entire team through mentorship and training.
Bachelor's degree in Engineering (Mechanical, Electrical/Electronics, Biomedical). Master's degree preferred.
5+ years' systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience preferred.
Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11 is required.
Knowledge of FDA QMS requirements, ISO-13485, European Medical Device Regulations and Canadian Medical Devices Regulations.
Experience with hardware and software interfaces, as well as the hardware and software architecture, is required.
Knowledge of PLC tools such as JAMA is required.
Knowledge of Agile principles of hardware engineering is preferred.
Willingness to travel up to 20% domestically and/or internationally.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.